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FDA Medication Tracker

← All approvals · Cancer · 2025

Avmapki Fakzynja Co-Pack (avutometinib and defactinib)

The FDA approved Avmapki Fakzynja Co-Pack (avutometinib and defactinib) on May 8, 2025 to treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy.
Brand name
Avmapki Fakzynja Co-Pack
Generic name
avutometinib and defactinib
FDA approval date
May 8, 2025
Approved use (FDA wording)
To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy
Company
Verastem Inc.
Application
NDA219616
Dosage form / route
CAPSULE, TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

AVMAPKI FAKZYNJA CO-PACK 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 indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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 sy…

Official sources

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