【FDA Approval Alert】Verastem’s avutometinib + defactinib Approved for KRAS-Mutated Low-Grade Serous Ovarian Cancer (May 8, 2025)
On May 8, 2025, the U.S. FDA granted accelerated approval to avutometinib + defactinib (Avmapki Fakzynja Co-pack) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy, including platinum-based regimens. Approval was based on the RAMP-201 trial (NCT04625270).
Disease Overview: KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)
LGSOC is a slow-growing subtype of ovarian cancer frequently harboring KRAS mutations. New targeted therapies are under development to improve outcomes in this rare malignancy.
Treatment Summary
- Drug Name: avutometinib + defactinib (Avmapki Fakzynja Co-pack)
- Company: Verastem, Inc.
- Approval Date: May 8, 2025
- Indication: KRAS-mutated recurrent LGSOC
- Mechanism of Action: MEK inhibitor + FAK inhibitor combination
- Pivotal Trial: RAMP-201 (NCT04625270)
- Key Efficacy: ORR 44% (95% CI: 31–58), DOR up to 31.1 months
Patient-Friendly Summary
Avmapki Fakzynja combines two oral agents that target tumor growth pathways in KRAS-mutated ovarian cancer, offering a new non-chemotherapy option for patients.
M&A Information
- Subsidiary: Not applicable (Verastem in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NASDAQ: VSTM)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
