New York, November 01, 2024 - PRISM MarketView - Verastem Oncology (NASDAQ:VSTM) has completed its New Drug Application (NDA) submission to the FDA for the combination treatment of avutometinib and defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) with a KRAS mutation. LGSOC is a rare and persistent form of ovarian cancer, distinct from high-grade serous ovarian cancer (HGSOC). It is highly recurrent, less responsive to chemotherapy, and ultimately fatal, with no FDA-approved treatments currently available. Approximately 6,000–8,000 women in the U.S. and 80,000 worldwide live with this disease, which predominantly affects younger women, with peak diagnoses between ages 20–30 and 50–60. The median survival is approximately ten years, with a significant impact on patients’ quality of life.
Verastem is seeking accelerated approval and priority review due to the urgent medical need. The FDA is expected to decide on the filing by the end of 2024, with a potential approval decision by mid-2025.
Avutometinib (a RAF/MEK clamp) and defactinib (a FAK inhibitor) work together to target key tumor growth pathways. Data from the Phase 2 RAMP 201 study showed promising results, with a 44% response rate, an average progression-free survival of 22 months, and a 70% disease control rate at six months. The treatment was generally well-tolerated, with only a 10% discontinuation rate due to side effects.
The FDA has previously granted Breakthrough Therapy Designation and Orphan Drug Designation to this combination for LGSOC. Verastem is conducting additional studies, including an international Phase 3 trial (RAMP 301), to confirm these findings and potentially expand the treatment to patients regardless of KRAS mutation status. This submission is a significant milestone as Verastem looks toward a mid-2025 decision, potentially bringing the first-ever FDA-approved treatment option to adults with recurrent KRAS mutant LGSOC in the United States.
Verastem is also set to participate in key upcoming industry events. The management team will be presenting at the 2024 Truist Securities BioPharma Symposium on November 7, 2024, and will host a fireside chat at the Guggenheim Healthcare Innovation Conference on Wednesday, November 13, 2024, at 9:00 am EDT.
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