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LABELS · 5e9b366c-3fc4-4178-bb80-687e21f9beff

XPOVIO

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
2026-05-12
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ). In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody ( 1.1 ). 1.1 Multiple Myeloma XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Full extracted label fields
application numbers
  1. NDA212306
boxed warning exact
    brand names
    1. XPOVIO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6dd2682-75a6-4863-90a8-a3197f6f78a8
    generic names
    1. SELINEXOR
    id
    5e9b366c-3fc4-4178-bb80-687e21f9beff
    indications and usage exact
    1. 1 INDICATIONS AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ). In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody ( 1.1 ). 1.1 Multiple Myeloma XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Karyopharm Therapeutics Inc.
      matched search terms
      1. myeloma
      package ndcs
      1. 72237-106-11
      2. 72237-106-01
      3. 72237-101-13
      4. 72237-101-03
      5. 72237-101-14
      6. 72237-101-04
      7. 72237-102-17
      8. 72237-102-07
      9. 72237-102-16
      10. 72237-102-06
      11. 72237-102-12
      12. 72237-102-02
      product ndcs
      1. 72237-101
      2. 72237-106
      3. 72237-102
      4. 72237-103
      5. 72237-104
      6. 72237-105
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration, Starting Dosage and Dosage Modifications for Adverse Reactions in Patients with Severe Hepatic Impairment ( 2.5 ) 9/2025 Indications and Usage, diffuse large B-cell lymphoma (DLBCL) - Accelerated Approval (Indication Removed) (1.2) 4/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2178395
      2. 2178402
      3. 2178406
      4. 2178407
      5. 2382989
      6. 2382990
      7. 2548732
      8. 2548733
      9. 2548735
      10. 2548736
      11. 2548738
      12. 2548739
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%225e9b366c-3fc4-4178-bb80-687e21f9beff%22
      spl effective date
      2026-05-12
      spl effective time
      20260512
      spl set id
      f6dd2682-75a6-4863-90a8-a3197f6f78a8
      spl version
      18
      substance names
      1. SELINEXOR
      uniis
      1. 31TZ62FO8F
      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
      Drugs@FDA application source records
      1. application number
        NDA212306
        payload
        all indexed label documents
        1. Appl No
          212306
          Application Docs Date
          2019-07-03 00:00:00
          Application Docs ID
          59230
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          212306
          Application Docs Date
          2020-06-22 00:00:00
          Application Docs ID
          63657
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          212306
          Application Docs Date
          2020-12-18 00:00:00
          Application Docs ID
          65621
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          212306
          Application Docs Date
          2022-03-29 00:00:00
          Application Docs ID
          70642
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        5. Appl No
          212306
          Application Docs Date
          2022-07-19 00:00:00
          Application Docs ID
          71600
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        6. Appl No
          212306
          Application Docs Date
          2025-03-12 00:00:00
          Application Docs ID
          81545
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        7. Appl No
          212306
          Application Docs Date
          2025-09-26 00:00:00
          Application Docs ID
          83575
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        8. Appl No
          212306
          Application Docs Date
          2026-05-05 00:00:00
          Application Docs ID
          85831
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          212306
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2026-04-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          212306
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2025-09-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          212306
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2025-03-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          212306
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2022-07-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          212306
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2022-03-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          212306
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2020-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          212306
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-06-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          212306
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-07-03 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA212306
        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
        2026-04-23
        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
          212306
          Application Docs Date
          2026-05-05 00:00:00
          Application Docs ID
          85831
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        official application record
        Appl No
        212306
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        KARYOPHARM THERAPS
        openfda application present
        true
        products
        1. Active Ingredient
          SELINEXOR
          Appl No
          212306
          Drug Name
          XPOVIO
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          20MG
          marketing status
          1. Prescription
        2. Active Ingredient
          SELINEXOR
          Appl No
          212306
          Drug Name
          XPOVIO
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          40MG
          marketing status
          1. Prescription
        3. Active Ingredient
          SELINEXOR
          Appl No
          212306
          Drug Name
          XPOVIO
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Prescription
        4. Active Ingredient
          SELINEXOR
          Appl No
          212306
          Drug Name
          XPOVIO
          Form
          TABLET;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          1
          Strength
          60MG
          marketing status
          1. Prescription
        5. Active Ingredient
          SELINEXOR
          Appl No
          212306
          Drug Name
          XPOVIO
          Form
          TABLET;ORAL
          Product No
          005
          Reference Drug
          1
          Reference Standard
          0
          Strength
          10MG
          marketing status
          1. Prescription
        6. Active Ingredient
          SELINEXOR
          Appl No
          212306
          Drug Name
          XPOVIO
          Form
          TABLET;ORAL
          Product No
          006
          Reference Drug
          1
          Reference Standard
          0
          Strength
          80MG
          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. NDA212306
      brand names
      1. XPOVIO
      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
      432
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ). In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to a
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      source field
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      source text sha256
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      start
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      current approval status
      not_reconciled
      duplicate text group
      dup-7bc6970a00185a42ee71
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. SELINEXOR
      id
      ind-span-6c9885f090abe6aa5947
      label id
      5e9b366c-3fc4-4178-bb80-687e21f9beff
      positive predicate support span
      end
      70
      end exclusive
      true
      exact text
      is a nuclear export inhibitor indicated
      label id
      5e9b366c-3fc4-4178-bb80-687e21f9beff
      offset unit
      unicode_code_points
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      source field
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      source text sha256
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      qualifier mentions
      1. context exact
        tion with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior
        kind
        age
        polarity
        not_inferred
        span
        end
        156
        end exclusive
        true
        exact text
        adult patients
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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      2. context exact
        e for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ).
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        227
        end exclusive
        true
        exact text
        who have received at least one prior therapy ( 1
        label id
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        offset unit
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        source field
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        source text sha256
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      3. context exact
        S AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ).
        kind
        regimen
        polarity
        not_inferred
        span
        end
        227
        end exclusive
        true
        exact text
        In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1
        label id
        5e9b366c-3fc4-4178-bb80-687e21f9beff
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        source field
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        source text sha256
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      regulatory links
        schema version
        0.1.0
        source batch sha256
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        source defined aliases
          source span
          end
          232
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ).
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225e9b366c-3fc4-4178-bb80-687e21f9beff%22
          spl effective date
          2026-05-12
          spl set id
          f6dd2682-75a6-4863-90a8-a3197f6f78a8
          spl version
          18
          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 · positive indication candidate
          application numbers
          1. NDA212306
          brand names
          1. XPOVIO
          classification reasons
          1. inherited_predicate_from_same_label_section_requires_review
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          750
          end exclusive
          true
          exact text
          a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ). In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody ( 1.1 ). 1.1 Multiple Myeloma XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVI
          label id
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          current approval status
          not_reconciled
          duplicate text group
          dup-0cc8feab63af3b97ee30
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          generic names
          1. SELINEXOR
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          label id
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          positive predicate support span
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          end exclusive
          true
          exact text
          is a nuclear export inhibitor indicated
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          qualifier mentions
          1. context exact
            In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have recei
            kind
            age
            polarity
            not_inferred
            span
            end
            302
            end exclusive
            true
            exact text
            adult patients
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          2. context exact
            hibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody ( 1.1 ).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            545
            end exclusive
            true
            exact text
            CD38 monoclonal antibody ( 1
            label id
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            offset unit
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          3. context exact
            with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disea
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            351
            end exclusive
            true
            exact text
            relapsed or refractory multiple myeloma who
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            offset unit
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            source text sha256
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            start
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          4. context exact
            received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            462
            end exclusive
            true
            exact text
            refractory to at least two proteasome inhibit
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            offset unit
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            source field
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