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

Regulatory approval published by the Food and Drug Administration.

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	KRAS p.G12C	Low-Grade Serous Ovarian Cancer	Avutometinib, Defactinib
Sensitivity (+)	KRAS p.G12V	Low-Grade Serous Ovarian Cancer	Avutometinib, Defactinib