Avutometinib and defactinib (Avmapki Fakzynja Co-Pack)

Key facts

• The FDA indication requires recurrent low-grade serous ovarian cancer with a KRAS mutation and prior systemic therapy.
• The product contains two medicines: avutometinib and defactinib.
• Accelerated approval means continued approval may depend on verification of clinical benefit in confirmatory evidence.
• The FDA label describes important eye, skin, muscle, liver, lung, and embryo-fetal safety risks.

Why biomarker testing matters

The approved population is defined by a KRAS mutation. The FDA approval study used tumor testing to identify eligible patients.

A drug name or cancer type alone is not enough to determine eligibility; the complete pathology, molecular result, treatment history, and current label matter.

Common and serious adverse reactions

The FDA label reports common reactions and laboratory abnormalities including nausea, diarrhea, fatigue, rash, musculoskeletal pain, edema, liver-test changes, and creatine phosphokinase increases.

The label also includes monitoring and management instructions for ocular toxicity, skin toxicity, muscle injury, liver toxicity, lung toxicity, and embryo-fetal harm.

Primary sources

• FDA: accelerated approval of avutometinib with defactinib — FDA approval notification dated May 8, 2025.
• FDA: Avmapki Fakzynja Co-Pack prescribing information — FDA label describing the indication, dosing, warnings, and adverse reactions.