What Was Approved?
On May 8, 2025, the U.S. Food and Drug Administration granted accelerated approval to Avmapki Fakzynja Co-Pack (avutometinib and defactinib) for adults with KRAS-mutated recurrent low-grade serous ovarian cancer, or LGSOC, who have received prior systemic therapy.
The treatment is specifically for tumors with a KRAS mutation.
What Is Avmapki Fakzynja Co-Pack?
The co-pack contains two oral targeted medicines:
- Avmapki (avutometinib)
- Fakzynja (defactinib)
They target signaling pathways involved in the growth of KRAS-mutated low-grade serous ovarian cancer.
How Is It Taken?
The FDA-approved regimen includes:
Avutometinib 3.2 mg by mouth twice weekly on Days 1 and 4
and
Defactinib 200 mg by mouth twice daily
for the first 3 weeks of each 4-week cycle.
Treatment generally continues until disease progression or unacceptable toxicity.
Why Was It Granted Accelerated Approval?
Approval was based on results from the RAMP-201 study in adults with KRAS-mutated recurrent LGSOC after previous systemic treatment.
The indication was approved based on tumor response rate and duration of response, and continued approval may depend on confirmatory evidence.
What Are Important Safety Concerns?
The FDA label includes important precautions for ocular toxicity.
Eye-related adverse reactions can include:
- Vision changes
- Dry eye
- Vitreous abnormalities
- Retinal detachment
Comprehensive eye examinations are recommended before treatment and periodically during therapy.
Serious skin reactions can also occur, and the FDA label recommends preventive skin treatment during the early treatment cycles.
Bottom Line
Avmapki Fakzynja Co-Pack (avutometinib and defactinib) is an FDA-approved oral combination for adults with KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy.
Because treatment requires KRAS testing and can cause significant eye and skin toxicity, patients require specialist oncology monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Grants Accelerated Approval to Avutometinib and Defactinib for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer, May 8, 2025.
- U.S. Food and Drug Administration (FDA) — Avmapki Fakzynja Co-Pack Prescribing Information, May 2025.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.