Avutometinib

FDA received NDA for avutometinib plus defactinib for recurrent KRAS-mutant low-grade serous ovarian cancer. Phase 2 RAMP 201 trial data showed 44% ORR in KRAS-mutant patients and 31% in overall population. Median PFS was 22 months in KRAS-mutant and 12.8 months in KRAS wild-type patients. Verastem Oncology aims for potential FDA approval by mid-2025.

The FDA has completed the rolling NDA for avutometinib and defactinib, targeting recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The combination, granted orphan drug designation, aims to address the unmet need for specific LGSOC treatments. Preliminary data from the FRAME and RAMP 201 trials indicate a 44% ORR and 22-month median PFS in KRAS mutant LGSOC patients, with ongoing enrollment for the RAMP 301 phase 3 trial. Verastem Oncology anticipates potential FDA approval by mid-2025.

Verastem Oncology completed the rolling NDA submission to the FDA for avutometinib and defactinib combination therapy for low-grade serous ovarian cancer, seeking priority review. The submission is based on Phase II RAMP 201 study results showing a 44% overall response rate and 22-month median progression-free survival in KRAS mutant patients. The treatment received breakthrough therapy and orphan drug designations.

Verastem Oncology completed a rolling NDA submission to the FDA for avutometinib/defactinib as a therapy for recurrent KRAS-mutated LGSOC, with a priority review requested. The regimen showed a 31% overall response rate and a median PFS of 12.9 months, potentially becoming the first FDA-approved treatment for this condition.

Verastem Oncology submitted a New Drug Application to the FDA for avutometinib plus defactinib to treat recurrent KRAS-mutant, low-grade serous ovarian cancer, a rare disease with no current FDA-approved treatments. The combination targets RAF/MEK and FAK pathways, potentially offering a new treatment paradigm. The application includes positive results from the RAMP 201 study, showing a 44% response rate and 22-month median progression-free survival in KRAS-mutant patients.

The FDA received a rolling NDA for avutometinib and defactinib to treat recurrent KRAS-mutant low-grade serous ovarian cancer. The NDA is supported by the phase 2 RAMP 201 trial data, showing a 44% ORR in KRAS-mutant patients and 31% in the overall population. The combination aims to change the treatment paradigm for this cancer type, with potential FDA approval planned for mid-2025.

Verastem Oncology completes NDA submission to FDA for avutometinib and defactinib combination in recurrent KRAS mutant low-grade serous ovarian cancer, with potential approval by mid-2025.

Chugai Pharmaceutical announced Verastem Oncology completed a rolling NDA to the FDA for avutometinib plus defactinib, targeting recurrent KRAS mutant low-grade serous ovarian cancer. Avutometinib, developed by Chugai, is under clinical development by Verastem.

Chugai Pharmaceutical announced Verastem Oncology completed a rolling NDA to the FDA for avutometinib plus defactinib, targeting recurrent KRAS mutant low-grade serous ovarian cancer. Avutometinib, developed by Chugai, is under clinical development by Verastem Oncology.

Verastem Oncology submitted an NDA to the FDA for avutometinib and defactinib, targeting recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC), with no current FDA-approved treatments. Seeking accelerated approval, a decision is expected by mid-2025. The combination showed a 44% ORR and 22 months median PFS in trials.