Avmapki Fakzynja Co-Pack FDA Approval History
FDA Approved: Yes (First approved May 8, 2025)
Brand name: Avmapki Fakzynja Co-Pack
Generic name: avutometinib and defactinib, co-packaged
Dosage form: Capsules/Tablets
Company: Verastem Oncology
Treatment for: Ovarian Cancer
Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated recurrent low-grade serous ovarian cancer.
- 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Development timeline for Avmapki Fakzynja Co-Pack
Further information
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