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STATUS · fda-aa-95e6f93e3ea1b6e68c48

Lunsumio (mosunetuzumab-axgb)

Open original source → · Download preserved record

This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Source status category
ongoing
Event date
2022-12-22
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2022-12-22
accelerated approval date source text
12/22/2022
brand name hint
Lunsumio
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Lunsumio (mosunetuzumab-axgb)
generic name hint
mosunetuzumab-axgb
id
fda-aa-95e6f93e3ea1b6e68c48
indication exact
Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
original projected completion source text
12/31/2025
post marketing requirement exact
4375-1: Conduct a randomized clinical trial in patients with relapsed or refractory follicular lymphoma (FL), with patients randomized to receive mosunetuzumab in combination with lenalidomide or rituximab in combination with lenalidomide. The primary endpoint should be PFS, with secondary endpoints that include RR and OS. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with FL and allow for interpretation of the results in these patient populations.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Lunsumio (mosunetuzumab-axgb)
      1. links
          text
          Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
        1. links
            text
            12/22/2022
          1. links
              text
              4375-1: Conduct a randomized clinical trial in patients with relapsed or refractory follicular lymphoma (FL), with patients randomized to receive mosunetuzumab in combination with lenalidomide or rituximab in combination with lenalidomide. The primary endpoint should be PFS, with secondary endpoints that include RR and OS. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with FL and allow for interpretation of the results in these patient populations.
            1. links
                text
                12/31/2025
              source provenance
              bytes
              102185
              file
              /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
              http status
              200
              retrieved at
              2026-09-09T23:35:15.160724+00:00
              sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              source page date Modified text
              Wed, 09/09/2026 - 00:00
              source page date Published text
              Wed, 09/09/2026 - 12:45
              source row index
              34
              source table headers
              1. Drug Name
              2. Accelerated Approval (AA) Indication
              3. AA Date
              4. AA Post-Marketing Requirement
              5. Original Projected Completion 1
              source table index
              0
              source url
              https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
              status applies to
              This exact indication and regimen, not every use of this drug
              status category
              ongoing
              status event date
              2022-12-22
              status event date meaning
              Original accelerated approval date; ongoing status observed at source retrieval
              traditional approval date
              Source null
              verification flags
                verification status
                official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
                withdrawal date
                Source null
                Source correspondence records
                matching
                drug name exact
                Lunsumio (mosunetuzumab-axgb)
                fda status record id
                fda-aa-95e6f93e3ea1b6e68c48
                indication exact
                Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-a2ba7dcc43045d6abc60
                2. ind-span-37f328390d10fb9d1efd
                source provenance
                bytes
                102185
                file
                /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
                http status
                200
                retrieved at
                2026-09-09T23:35:15.160724+00:00
                sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                source page date Modified text
                Wed, 09/09/2026 - 00:00
                source page date Published text
                Wed, 09/09/2026 - 12:45
                status category
                ongoing
                unmatched meaning
                Source null
                links
                1. package id
                  fda-label-library-8184721b7b3bb86692f8276c
                  correspondence id
                  correspondence-8a4d040a845274b82fda747a
                  span id
                  ind-span-37f328390d10fb9d1efd
                  status id
                  fda-aa-95e6f93e3ea1b6e68c48
                  match method
                  whole_indication_literal_normalized_substring
                  scope relationship
                  whole_fda_indication_text_present
                  matching review status
                  source_comparison_only_clinical_review_pending
                  payload
                  candidate source span
                  end
                  621
                  end exclusive
                  true
                  exact text
                  1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
                  label id
                  492d93a0-02ba-4424-a425-1965749094f6
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  a27a4387afb4ebc6d1d96b7521b99623c57dd9124a6577c579fe85476f712b9b
                  start
                  447
                  fda indication exact
                  Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
                  fda source row index
                  34
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-95e6f93e3ea1b6e68c48
                  interpretation
                  Source wording correspondence to a dated FDA status row; current approval not certified
                  match method
                  whole_indication_literal_normalized_substring
                  matching review status
                  source_comparison_only_clinical_review_pending
                  scope relationship
                  whole_fda_indication_text_present
                  status category
                  ongoing
                  status event date
                  2022-12-22
                  supporting anchor spans
                  1. package id
                    fda-label-library-8184721b7b3bb86692f8276c
                    correspondence id
                    correspondence-b9f484cd7d134993316a3a7f
                    span id
                    ind-span-a2ba7dcc43045d6abc60
                    status id
                    fda-aa-95e6f93e3ea1b6e68c48
                    match method
                    whole_indication_literal_normalized_substring
                    scope relationship
                    whole_fda_indication_text_present
                    matching review status
                    source_comparison_only_clinical_review_pending
                    payload
                    candidate source span
                    end
                    220
                    end exclusive
                    true
                    exact text
                    1 INDICATIONS AND USAGE LUNSUMIO 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
                    492d93a0-02ba-4424-a425-1965749094f6
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    a27a4387afb4ebc6d1d96b7521b99623c57dd9124a6577c579fe85476f712b9b
                    start
                    0
                    fda indication exact
                    Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
                    fda source row index
                    34
                    fda source sha256
                    8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                    fda status record id
                    fda-aa-95e6f93e3ea1b6e68c48
                    interpretation
                    Source wording correspondence to a dated FDA status row; current approval not certified
                    match method
                    whole_indication_literal_normalized_substring
                    matching review status
                    source_comparison_only_clinical_review_pending
                    scope relationship
                    whole_fda_indication_text_present
                    status category
                    ongoing
                    status event date
                    2022-12-22
                    supporting anchor spans

                    Preserved source evidence · Not medical advice