FDA Grants Accelerated Approval to Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib)
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, announced the U.S. Food and Drug Administration (FDA) approval of Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy. Avmapki Fakzynja Co-Pack is the first and only FDA-approved medicine for this disease. This indication is approved under accelerated approval based on the 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. Avmapki plus Fakzynja is only commercially available in the U.S. as an oral combination co-pack with the two prescription products, known as “Avmapki Fakzynja Co-Pack.”
https://www.med-chemist.com/2025/11/f...