AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)
Growthavutometinib potassium and defactinib hydrochloride
NDAORALCAPSULE, TABLETPriority Review
Approved
May 2025
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (avutometinib potassium and defactinib hydrochloride) by Verastem Oncology is mek1 inhibitor. Approved for ovarian cancer. First approved in 2025.
Drug data last refreshed 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVMAPKI FAKZYNJA is a copackaged oral combination of avutometinib (MEK1/2 inhibitor) and defactinib (FAK/Pyk2 inhibitor) approved for ovarian cancer. The combination targets the RAS/RAF/MEK/ERK pathway while simultaneously inhibiting focal adhesion kinase signaling to enhance anti-tumor activity in KRAS-mutant and other resistant cancers. This dual-mechanism approach addresses tumors with activation of both MAPK and FAK pathways.
Growth16.4 years to LOE
Early-stage launch phase with emerging commercial team; market share opportunities in ovarian cancer remain undefined as product gains real-world adoption.
Mechanism of Action
MEK1 inhibitor. Avutometinib induces the formation of inactive RAF/MEK complexes and prevents phosphorylation of MEK1/2 by RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Avutometinib inhibited MEK1/2 and ERK1/2 phosphorylation and proliferation of tumor cell lines…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.