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LABELS · e6def323-179c-432e-957d-fc4ea03e1b78

AVMAPKI FAKZYNJA CO-PACK

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
2025-05-01
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 , 14 )
Full extracted label fields
application numbers
  1. NDA219616
boxed warning exact
    brand names
    1. AVMAPKI FAKZYNJA CO-PACK
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=65889527-1406-45df-8a85-e2690dcf427d
    generic names
    1. AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE
    id
    e6def323-179c-432e-957d-fc4ea03e1b78
    indications and usage exact
    1. 1 INDICATIONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 , 14 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Verastem Inc.
      matched search terms
      1. cancer
      2. tumor
      package ndcs
      1. 71779-623-01
      2. 71779-660-02
      3. 71779-630-01
      product ndcs
      1. 71779-623
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
          rxcuis
          1. 2714507
          2. 2714513
          3. 2714520
          4. 2714526
          5. 2714921
          6. 2714922
          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
          results
          limit
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          skip
          700
          total
          830
          sha256
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          url
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22e6def323-179c-432e-957d-fc4ea03e1b78%22
          spl effective date
          2025-05-01
          spl effective time
          20250501
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          spl version
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          substance names
            uniis
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              Drugs@FDA application source records
              1. application number
                NDA219616
                payload
                all indexed label documents
                1. Appl No
                  219616
                  Application Docs Date
                  2025-05-08 00:00:00
                  Application Docs ID
                  82255
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  1
                  Submission Type
                  ORIG
                all submission records
                1. Appl No
                  219616
                  Review Priority
                  PRIORITY
                  Submission Class Code ID
                  7
                  Submission No
                  1
                  Submission Status
                  AP
                  Submission Status Date
                  2025-05-08 00:00:00
                  Submission Type
                  ORIG
                  Submissions Public Notes
                application number
                NDA219616
                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
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                latest label selection rule
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                latest posted label documents
                1. Appl No
                  219616
                  Application Docs Date
                  2025-05-08 00:00:00
                  Application Docs ID
                  82255
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  1
                  Submission Type
                  ORIG
                official application record
                Appl No
                219616
                Appl Public Notes
                Appl Type
                NDA
                Sponsor Name
                VERASTEM INC
                openfda application present
                true
                products
                1. Active Ingredient
                  AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
                  Appl No
                  219616
                  Drug Name
                  AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)
                  Form
                  CAPSULE, TABLET;ORAL
                  Product No
                  001
                  Reference Drug
                  1
                  Reference Standard
                  1
                  Strength
                  EQ 0.8MG BASE;EQ 200MG BASE
                  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. NDA219616
              brand names
              1. AVMAPKI FAKZYNJA CO-PACK
              classification reasons
              1. explicit_positive_indication_predicate
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              clinical review status
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              content role
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              408
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upo
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              generic names
              1. AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE
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              is indicated
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              qualifier mentions
              1. context exact
                AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cance
                kind
                age
                polarity
                not_inferred
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                adult patients
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              2. context exact
                -PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
                kind
                biomarker
                polarity
                not_inferred
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                true
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                KRAS -mutated recurrent low-grade serous ova
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              3. context exact
                ated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
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                recurrent low-grade serous ovarian cancer (L
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              4. context exact
                -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
                kind
                prior_therapy_or_line
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                not_inferred
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                207
                end exclusive
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                exact text
                who have received prior systemic therapy
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              regulatory links
              1. candidate source span
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                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
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                source text sha256
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                fda indication exact
                Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
                fda source row index
                14
                fda source sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                fda status record id
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                interpretation
                Source wording correspondence to a dated FDA status row; current approval not certified
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                whole_fda_indication_text_present
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                supporting anchor spans
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                  true
                  exact text
                  1 INDICATIONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
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                  spl effective date
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                  Source null
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                  Source null
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                  tumor_directed_candidate

                  Read indication-specific status → · whole_fda_indication_text_present

                  Passage 2 · approval contingency
                  application numbers
                  1. NDA219616
                  brand names
                  1. AVMAPKI FAKZYNJA CO-PACK
                  classification reasons
                  1. approval_contingency_words
                  clinical review status
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                  true
                  exact text
                  IONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and def
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                        This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ].
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                        source url
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                        spl effective date
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                        Passage 3 · approval contingency
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                        ian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian
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                              Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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                              spl effective date
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                              Passage 4 · positive indication candidate
                              application numbers
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                              brand names
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                              nse rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and descriptio
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                              current approval status
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                              extraction review status
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                              generic names
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                              id
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                              label id
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                              is indicated
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                              qualifier mentions
                              1. context exact
                                , each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cance
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                                                    Preserved source evidence · Not medical advice