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STATUS · fda-aa-fcde42e58913c9b804a0

Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets)

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

Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy

Source status category
ongoing
Event date
2025-05-08
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2025-05-08
accelerated approval date source text
5/8/2025
brand name hint
Avmapki Fakzynja Co-Pack
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets)
generic name hint
avutometinib capsules; defactinib tablets
id
fda-aa-fcde42e58913c9b804a0
indication exact
Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
original projected completion source text
6/30/2028
post marketing requirement exact
4835-1: Complete the ongoing trial titled, “RAMP 301: A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)”, and provide the progression-free survival and the final overall survival analyses, intended to describe and verify the clinical benefit of avutometinib and defactinib in combination in adult patients with recurrent, KRAS-mutated low grade serous ovarian cancer. Include central KRAS testing results for all patients.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low
source cells exact
  1. links
      text
      Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low
      text
      Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
    2. links
        text
        5/8/2025
      1. links
          text
          4835-1: Complete the ongoing trial titled, “RAMP 301: A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)”, and provide the progression-free survival and the final overall survival analyses, intended to describe and verify the clinical benefit of avutometinib and defactinib in combination in adult patients with recurrent, KRAS-mutated low grade serous ovarian cancer. Include central KRAS testing results for all patients.
        1. links
            text
            6/30/2028
          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
          14
          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
          2025-05-08
          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
            Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets)
            fda status record id
            fda-aa-fcde42e58913c9b804a0
            indication exact
            Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-7e58d72a53fa530a2671
            2. ind-span-549094f18d61bb29a175
            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-01b4877d564d64959359170f
              span id
              ind-span-7e58d72a53fa530a2671
              status id
              fda-aa-fcde42e58913c9b804a0
              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
              208
              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.
              label id
              e6def323-179c-432e-957d-fc4ea03e1b78
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              c49358f3c638cf1ecef62088377a641f8a7504d4504de48a5b95af68c1ce9520
              start
              0
              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
              fda-aa-fcde42e58913c9b804a0
              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
              2025-05-08
              supporting anchor spans
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-35d15481f32aa642cdc38908
                span id
                ind-span-549094f18d61bb29a175
                status id
                fda-aa-fcde42e58913c9b804a0
                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
                739
                end exclusive
                true
                exact text
                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.
                label id
                e6def323-179c-432e-957d-fc4ea03e1b78
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                c49358f3c638cf1ecef62088377a641f8a7504d4504de48a5b95af68c1ce9520
                start
                484
                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
                fda-aa-fcde42e58913c9b804a0
                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
                2025-05-08
                supporting anchor spans

                Preserved source evidence · Not medical advice