Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · cc3e8671-e1bd-494e-bedb-de8dc0e2f482

Lunsumio Velo

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-06-29
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Full extracted label fields
application numbers
  1. BLA761263
boxed warning exact
  1. WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )
brand names
  1. Lunsumio Velo
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
generic names
  1. MOSUNETUZUMAB
id
cc3e8671-e1bd-494e-bedb-de8dc0e2f482
indications and usage exact
  1. 1 INDICATIONS AND USAGE LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genentech, Inc.
    matched search terms
    1. lymphoma
    package ndcs
    1. 50242-177-01
    2. 50242-201-01
    product ndcs
    1. 50242-177
    2. 50242-201
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 2729433
      2. 2729436
      3. 2729439
      4. 2729442
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      600
      total
      830
      sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=600&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
      spl effective date
      2026-06-29
      spl effective time
      20260629
      spl set id
      6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
      spl version
      4
      substance names
      1. MOSUNETUZUMAB
      uniis
      1. LDJ89SS0YG
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA761263
        payload
        all indexed label documents
        1. Appl No
          761263
          Application Docs Date
          2022-12-23 00:00:00
          Application Docs ID
          73017
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761263
          Application Docs Date
          2024-11-25 00:00:00
          Application Docs ID
          80333
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        3. Appl No
          761263
          Application Docs Date
          2026-01-06 00:00:00
          Application Docs ID
          84692
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          761263
          Application Docs Date
          2026-07-06 00:00:00
          Application Docs ID
          86341
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761263
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-12-22 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761263
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2024-11-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761263
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2025-12-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761263
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2026-06-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761263
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-06-18
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          761263
          Application Docs Date
          2026-07-06 00:00:00
          Application Docs ID
          86341
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        official application record
        Appl No
        761263
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        GENENTECH INC
        openfda application present
        true
        products
        1. Active Ingredient
          MOSUNETUZUMAB-AXGB
          Appl No
          761263
          Drug Name
          LUNSUMIO
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          1MG/ML
          marketing status
          1. Prescription
        2. Active Ingredient
          MOSUNETUZUMAB-AXGB
          Appl No
          761263
          Drug Name
          LUNSUMIO
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          0
          Reference Standard
          0
          Strength
          30MG/30ML
          marketing status
          1. Prescription
        3. Active Ingredient
          MOSUNETUZUMAB-AXGB
          Appl No
          761263
          Drug Name
          LUNSUMIO VELO
          Form
          INJECTABLE;INJECTION
          Product No
          003
          Reference Drug
          0
          Reference Standard
          0
          Strength
          5MG/0.5ML
          marketing status
          1. Prescription
        4. Active Ingredient
          MOSUNETUZUMAB-AXGB
          Appl No
          761263
          Drug Name
          LUNSUMIO VELO
          Form
          INJECTABLE;INJECTION
          Product No
          004
          Reference Drug
          0
          Reference Standard
          0
          Strength
          45MG/ML
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. BLA761263
      brand names
      1. Lunsumio Velo
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      425
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a conf
      label id
      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-ab9ee0c13e0520d7faf2
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. MOSUNETUZUMAB
      id
      ind-span-dfde73668caae0a5e9b1
      label id
      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
      positive predicate support span
      end
      96
      end exclusive
      true
      exact text
      is a bispecific CD20-directed CD3 T-cell engager indicated
      label id
      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
      start
      38
      qualifier mentions
      1. context exact
        -directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two o
        kind
        age
        polarity
        not_inferred
        span
        end
        132
        end exclusive
        true
        exact text
        adult patients
        label id
        cc3e8671-e1bd-494e-bedb-de8dc0e2f482
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
        start
        118
      2. context exact
        1 INDICATIONS AND USAGE LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refracto
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        98
        end exclusive
        true
        exact text
        CD20-directed CD3 T-cell engager indicated f
        label id
        cc3e8671-e1bd-494e-bedb-de8dc0e2f482
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
        start
        54
      3. context exact
        engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        181
        end exclusive
        true
        exact text
        relapsed or refractory follicular lymphoma
        label id
        cc3e8671-e1bd-494e-bedb-de8dc0e2f482
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
        start
        138
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        source defined aliases
          source span
          end
          225
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
          label id
          cc3e8671-e1bd-494e-bedb-de8dc0e2f482
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
          spl effective date
          2026-06-29
          spl set id
          6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
          spl version
          4
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · approval contingency
          application numbers
          1. BLA761263
          brand names
          1. Lunsumio Velo
          classification reasons
          1. approval_contingency_words
          clinical review status
          pending
          content role
          approval_contingency
          context span
          end
          504
          end exclusive
          true
          exact text
          NSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated f
          label id
          cc3e8671-e1bd-494e-bedb-de8dc0e2f482
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
          start
          26
          current approval status
          not_reconciled
          duplicate text group
          dup-c7cd8465431f77cc9416
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. MOSUNETUZUMAB
          id
          ind-span-4c4fd9cd5aa5c9c33461
          label id
          cc3e8671-e1bd-494e-bedb-de8dc0e2f482
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
              source defined aliases
                source span
                end
                304
                end exclusive
                true
                exact text
                This indication is approved under accelerated approval based on response rate.
                label id
                cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                start
                226
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
                spl effective date
                2026-06-29
                spl set id
                6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
                spl version
                4
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                not_applicable
                Passage 3 · approval contingency
                application numbers
                1. BLA761263
                brand names
                1. Lunsumio Velo
                classification reasons
                1. approval_contingency_words
                clinical review status
                pending
                content role
                approval_contingency
                context span
                end
                643
                end exclusive
                true
                exact text
                treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indica
                label id
                cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                start
                105
                current approval status
                not_reconciled
                duplicate text group
                dup-781ed2c87b3088cff072
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. MOSUNETUZUMAB
                id
                ind-span-4be60377893747255c41
                label id
                cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                    source defined aliases
                      source span
                      end
                      443
                      end exclusive
                      true
                      exact text
                      Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                      label id
                      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                      start
                      305
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
                      spl effective date
                      2026-06-29
                      spl set id
                      6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
                      spl version
                      4
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      not_applicable
                      Passage 4 · unclassified context
                      application numbers
                      1. BLA761263
                      brand names
                      1. Lunsumio Velo
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      651
                      end exclusive
                      true
                      exact text
                      approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is
                      label id
                      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                      start
                      244
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-4c229251abb7ea9b0934
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. MOSUNETUZUMAB
                      id
                      ind-span-2a7e0b83f820877fd1c3
                      label id
                      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                          source defined aliases
                            source span
                            end
                            451
                            end exclusive
                            true
                            exact text
                            ( 1.1 )
                            label id
                            cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                            start
                            444
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
                            spl effective date
                            2026-06-29
                            spl set id
                            6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
                            spl version
                            4
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            unclear
                            Passage 5 · positive indication candidate
                            application numbers
                            1. BLA761263
                            brand names
                            1. Lunsumio Velo
                            classification reasons
                            1. explicit_positive_indication_predicate
                            2. tumor_or_malignant_hematology_words_in_positive_statement
                            clinical review status
                            pending
                            content role
                            positive_indication_candidate
                            context span
                            end
                            831
                            end exclusive
                            true
                            exact text
                            d under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description
                            label id
                            cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                            start
                            252
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-6d0657ed3b7b64c581fb
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. MOSUNETUZUMAB
                            id
                            ind-span-c2d5ddaf1039ac021b7a
                            label id
                            cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                            positive predicate support span
                            end
                            502
                            end exclusive
                            true
                            exact text
                            is indicated
                            label id
                            cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                            start
                            490
                            qualifier mentions
                            1. context exact
                              ar Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two o
                              kind
                              age
                              polarity
                              not_inferred
                              span
                              end
                              538
                              end exclusive
                              true
                              exact text
                              adult patients
                              label id
                              cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                              start
                              524
                            2. context exact
                              VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
                              kind
                              stage_or_setting
                              polarity
                              not_inferred
                              span
                              end
                              587
                              end exclusive
                              true
                              exact text
                              relapsed or refractory follicular lymphoma
                              label id
                              cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                              start
                              544
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                              source defined aliases
                                source span
                                end
                                631
                                end exclusive
                                true
                                exact text
                                1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
                                label id
                                cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                                start
                                452
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
                                spl effective date
                                2026-06-29
                                spl set id
                                6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
                                spl version
                                4
                                structured fields status
                                not_extracted_no_values_inferred_from_mentions
                                structured indication
                                age
                                Source null
                                approval pathway
                                Source null
                                biomarker and test
                                Source null
                                disease stage
                                Source null
                                limitations
                                Source null
                                line
                                Source null
                                prior therapy
                                Source null
                                regimen
                                Source null
                                tumor histology
                                Source null
                                use intent
                                tumor_directed_candidate
                                Passage 6 · approval contingency
                                application numbers
                                1. BLA761263
                                brand names
                                1. Lunsumio Velo
                                classification reasons
                                1. approval_contingency_words
                                clinical review status
                                pending
                                content role
                                approval_contingency
                                context span
                                end
                                879
                                end exclusive
                                true
                                exact text
                                y trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                label id
                                cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                                start
                                432
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-096600ffa67fcde3b47b
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. MOSUNETUZUMAB
                                id
                                ind-span-54537941d57dc2dbf20a
                                label id
                                cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                positive predicate support span
                                Source null
                                qualifier mentions
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                    source defined aliases
                                      source span
                                      end
                                      740
                                      end exclusive
                                      true
                                      exact text
                                      This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] .
                                      label id
                                      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                                      start
                                      632
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
                                      spl effective date
                                      2026-06-29
                                      spl set id
                                      6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
                                      spl version
                                      4
                                      structured fields status
                                      not_extracted_no_values_inferred_from_mentions
                                      structured indication
                                      age
                                      Source null
                                      approval pathway
                                      Source null
                                      biomarker and test
                                      Source null
                                      disease stage
                                      Source null
                                      limitations
                                      Source null
                                      line
                                      Source null
                                      prior therapy
                                      Source null
                                      regimen
                                      Source null
                                      tumor histology
                                      Source null
                                      use intent
                                      not_applicable
                                      Passage 7 · approval contingency
                                      application numbers
                                      1. BLA761263
                                      brand names
                                      1. Lunsumio Velo
                                      classification reasons
                                      1. approval_contingency_words
                                      clinical review status
                                      pending
                                      content role
                                      approval_contingency
                                      context span
                                      end
                                      879
                                      end exclusive
                                      true
                                      exact text
                                      th relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                      label id
                                      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                                      start
                                      541
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-781ed2c87b3088cff072
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. MOSUNETUZUMAB
                                      id
                                      ind-span-d6421137bb483f663e17
                                      label id
                                      cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                      positive predicate support span
                                      Source null
                                      qualifier mentions
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                          source defined aliases
                                            source span
                                            end
                                            879
                                            end exclusive
                                            true
                                            exact text
                                            Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
                                            label id
                                            cc3e8671-e1bd-494e-bedb-de8dc0e2f482
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            5eddb3f25b0dd5b7136c1fab725db5c6a5626cfdabc4ed21c0025e021ef92895
                                            start
                                            741
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%22cc3e8671-e1bd-494e-bedb-de8dc0e2f482%22
                                            spl effective date
                                            2026-06-29
                                            spl set id
                                            6a2b6dc2-48bd-4da7-a611-bc6bae2893c8
                                            spl version
                                            4
                                            structured fields status
                                            not_extracted_no_values_inferred_from_mentions
                                            structured indication
                                            age
                                            Source null
                                            approval pathway
                                            Source null
                                            biomarker and test
                                            Source null
                                            disease stage
                                            Source null
                                            limitations
                                            Source null
                                            line
                                            Source null
                                            prior therapy
                                            Source null
                                            regimen
                                            Source null
                                            tumor histology
                                            Source null
                                            use intent
                                            not_applicable

                                            Preserved source evidence · Not medical advice