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LABELS · 0080902a-fc95-4612-8df2-1fd00bbaed23

Elrexfio

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
2026-02-26
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce the risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ), Warnings and Precautions (5.1) ] . • Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . • Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity. ( 2.2 , 2.5 , 5.1 ) • Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) • ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )
Full extracted label fields
application numbers
  1. BLA761345
boxed warning exact
  1. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce the risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ), Warnings and Precautions (5.1) ] . • Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . • Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity. ( 2.2 , 2.5 , 5.1 ) • Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) • ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )
brand names
  1. Elrexfio
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6fea598-ff58-4a20-b5e8-8a51f37d8beb
generic names
  1. ELRANATAMAB-BCMM
id
0080902a-fc95-4612-8df2-1fd00bbaed23
indications and usage exact
  1. 1 INDICATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Pfizer Laboratories Div Pfizer Inc
    matched search terms
    1. myeloma
    package ndcs
    1. 0069-2522-01
    2. 0069-2522-02
    3. 0069-4494-01
    4. 0069-4494-02
    product ndcs
    1. 0069-2522
    2. 0069-4494
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration, Recommended Dosage ( 2.2 ) 7/2025 Dosage and Administration, Restarting ELREXFIO After Dosage Delay ( 2.4 ) 7/2025 Dosage and Administration, Preparation and Administration Instructions ( 2.6 ) 7/2025
    record type
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    routes
    1. SUBCUTANEOUS
    rxcuis
    1. 2644885
    2. 2644891
    3. 2644893
    4. 2644894
    source batch
    file
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    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
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    url
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    source url
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    spl effective date
    2026-02-26
    spl effective time
    20260226
    spl set id
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    spl version
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    substance names
    1. ELRANATAMAB
    uniis
    1. L0HR9A577V
    verification flags
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    Drugs@FDA application source records
    1. application number
      BLA761345
      payload
      all indexed label documents
      1. Appl No
        761345
        Application Docs Date
        2023-09-12 00:00:00
        Application Docs ID
        75408
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
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        Submission Type
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      2. Appl No
        761345
        Application Docs Date
        2025-07-11 00:00:00
        Application Docs ID
        82817
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      3. Appl No
        761345
        Application Docs Date
        2026-02-25 00:00:00
        Application Docs ID
        85159
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761345
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2026-02-19 00:00:00
        Submission Type
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        Submissions Public Notes
      2. Appl No
        761345
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2025-07-08 00:00:00
        Submission Type
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        Submissions Public Notes
      3. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2025-07-10 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
        761345
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2024-09-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761345
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2023-12-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761345
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2023-08-14 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      7. Appl No
        761345
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2026-03-25 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761345
      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
      2026-03-25
      latest label selection rule
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      latest posted label documents
      1. Appl No
        761345
        Application Docs Date
        2026-02-25 00:00:00
        Application Docs ID
        85159
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
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        Submission Type
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      official application record
      Appl No
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      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      PFIZER INC
      openfda application present
      true
      products
      1. Active Ingredient
        ELRANATAMAB
        Appl No
        761345
        Drug Name
        ELREXFIO
        Form
        SOLUTION;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        12MG
        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
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    brand names
    1. Elrexfio
    classification reasons
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    clinical review status
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    true
    exact text
    1 INDICATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon v
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    qualifier mentions
    1. context exact
      ATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have recei
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      polarity
      not_inferred
      span
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      end exclusive
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      exact text
      adult patients
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    2. context exact
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      end exclusive
      true
      exact text
      CD38 monoclonal antibody
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    3. context exact
      EXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, includi
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      not_inferred
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      relapsed or refractory multiple myeloma who
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    4. context exact
      adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
      kind
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      end exclusive
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      exact text
      who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
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    regulatory links
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        exact text
        1 INDICATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
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        Passage 2 · approval contingency
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        with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cel
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              This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] .
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              n immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at l
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                                          Preserved source evidence · Not medical advice