Avutometinib

Verastem Oncology's NDA for avutometinib and defactinib combo for recurrent LGSOC with KRAS mutation was accepted by FDA under Priority Review, with a PDUFA date of June 30, 2025. Based on Phase 2 RAMP 201 trial results, showing durable responses and good tolerability, it aims to address a current treatment gap. A Phase 3 trial, RAMP 301, is enrolling patients for further confirmation.

Verastem Oncology reports no dose-limiting toxicities in RAMP 203 Phase 1/2 study of avutometinib, sotorasib, and defactinib for KRAS G12C mutant NSCLC. Two of three patients showed initial tumor reductions of at least 20%. Enrollment continues, with an interim update planned for 2025.

Verastem, Inc. focuses on avutometinib for low-grade serous ovarian cancer, with potential FDA approval by mid-2025. The drug shows superior performance in KRAS mutant cases, though efficacy in KRAS wild-type patients is limited. Analysts predict price targets from $7 to $15 per share, with current trading below Fair Value.

The NDA for avutometinib and defactinib in recurrent KRAS mutant LGSOC is complete, aiming for FDA approval in mid-2025. This combination could be the first FDA-approved treatment for this rare, fatal ovarian cancer.

DelveInsight's report on KRAS Inhibitors covers market trends, epidemiology, and pipeline developments in the US, EU4, UK, and Japan. The market is driven by cancer incidence and personalized treatments, with key companies like Novartis, Roche, and Verastem Oncology leading in KRAS inhibitor therapies.

Verastem Oncology completed NDA submission for avutometinib and defactinib in KRAS mutant low-grade serous ovarian cancer, seeking accelerated approval and priority review. Positive safety and efficacy results from the RAMP 201 trial were presented at IGCS 2024. The company anticipates an FDA decision on the NDA by mid-2025 and is preparing for a potential U.S. launch.

Verastem Oncology submitted an NDA to the FDA for avutometinib and defactinib, targeting recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC), a rare cancer with no FDA-approved treatments. Seeking accelerated approval and priority review, a decision is expected by mid-2025, potentially marking the first FDA-approved treatment for this condition.

Verastem Oncology completed its NDA submission to the FDA for avutometinib and defactinib, potential first-in-class treatments for recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The combination aims to address significant unmet medical need, with preliminary data showing a 44% overall response rate and 22-month median progression-free survival. If approved, it would be the first FDA-approved treatment specifically for this rare cancer, with a potential decision expected by mid-2025.