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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	KRAS p.G12C	Low-Grade Serous Ovarian Cancer	Avutometinib, Defactinib
FDA (2)	KRAS p.G12V	Low-Grade Serous Ovarian Cancer	Avutometinib, Defactinib

Contributions

Date	Contributor	Description
2025-06-12	Van Allen lab	The FDA provided regular approval to taletrectinib for the treatment of patients with ROS1 positive non-small cell lung cancer, accelerated approval to telisotuzumab vedotin-tllv for the treatment of patients with non-squamous non-small cell lung cancer with high c-Met expression, and avutometinib in combination with defactinib (Avmapki Fakzynja co-pack) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer.
2025-05-08	Food and Drug Administration	Indication received accelerated approval.