Defactinib

The FDA is reviewing Verastem Oncology's application for avutometinib and defactinib to treat low-grade serous ovarian cancer (LGSOC) with KRAS mutations, potentially the first FDA-approved therapy for this group. A decision is expected by June 30, with a priority review shortening the process. Verastem is also conducting a Phase 3 trial to compare this combination against standard treatments, aiming for broader approval. The treatment targets the RAS/MAPK pathway, showing promise in trials with a 31% overall response rate, higher in KRAS mutation carriers.

FDA accepted a new drug application for avutometinib combined with defactinib, targeting recurrent low-grade serous ovarian cancer with KRAS mutation, granting priority review with a PDUFA action date of June 30, 2025. This combination could be the first FDA-approved treatment for LGSOC, showing a 31% overall response rate and median progression-free survival of 12.9 months in trials.

The Ovarian Cancer market is expected to grow significantly by 2034, driven by advancements in treatments from companies like AbbVie and Verastem Oncology. Key insights include decreasing diagnosed cases, emerging therapies, and FDA approvals for new treatments. The report covers epidemiology, market trends, and therapeutic developments in the US, EU4, UK, and Japan.

Chugai Pharmaceutical announced the FDA accepted Verastem Oncology's NDA for avutometinib and defactinib combo to treat recurrent KRAS mutant LGSOC, with a PDUFA action date of June 30, 2025. No advisory committee meeting is planned. Avutometinib was developed by Chugai, with Verastem handling clinical development.

FDA grants priority review for avutometinib/defactinib combo targeting KRAS-mutant recurrent low-grade serous ovarian cancer, with a target action date of June 30, 2025. Supported by phase 2 RAMP 201 trial data, showing durable responses and tolerability. Orphan drug designation also granted in 2024.

FDA prioritizes review of avutometinib/defactinib for KRAS-mutant recurrent low-grade serous ovarian cancer, with a target action date of June 30, 2025. Phase 2 RAMP 201 trial data supported the NDA, showing durable responses and tolerability. The combination received breakthrough therapy and orphan drug designations.

FDA granted priority review to avutometinib plus defactinib for recurrent low-grade serous ovarian cancer with KRAS mutation, targeting a June 30, 2025, decision. Supported by RAMP 201 trial data, showing durable responses and good tolerance. ORR was 31% overall, 44% for KRAS-mutated patients. Common AEs included nausea and diarrhea.

The FDA accepted an NDA for avutometinib and defactinib, targeting KRAS-mutated recurrent low-grade serous ovarian cancer, under accelerated approval. This combination could be the first FDA-approved treatment for this condition, with a PDUFA action date of June 30, 2025. The NDA is based on data from the phase 2 RAMP 201 trial, showing durable responses and good tolerance.

FDA accepted Verastem Oncology’s NDA for avutometinib with defactinib to treat recurrent LGSOC with KRAS mutation, granting priority review with a PDUFA date of June 30, 2025. Phase 2 RAMP 201 trial showed a 31% overall response rate, 44% in KRAS mutants, with a 31.1-month DOR.

Avutometinib/defactinib received FDA priority review for treating recurrent KRAS-mutant low-grade serous ovarian cancer, supported by phase 2 RAMP 201 trial results showing efficacy and safety. The NDA has a Prescription Drug User Fee Act date of June 30, 2025.