Regulatory approval

Published by the Food and Drug Administration. Accelerated

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 is written in the approval document.

Citation

Verastem Inc. Avmapki Fakzynja co-pack (avutometinib potassium; defactinib hydrochloride) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219616s000lbl.pdf. Revised May 2025. Accessed June 12, 2025.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) KRAS p.G12C Low-Grade Serous Ovarian Cancer Avutometinib, Defactinib
FDA (1) KRAS p.G12V Low-Grade Serous Ovarian Cancer Avutometinib, Defactinib