Avmapki Fakzynja co-pack (avutometinib potassium; defactinib hydrochloride) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

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 October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
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