NEW YORK – Verastem Oncology said on Monday the US Food and Drug Administration has accepted a new drug application (NDA) for its RAF/MEK clamp therapy avutometinib in combination with its FAK inhibitor defactinib for the treatment of patients with recurrent low-grade serous ovarian cancer who received at least one prior systemic therapy and have a KRAS mutation.
The FDA granted priority review to the NDA and is expected to make an approval decision by June 30, 2025. The agency also said it was not currently planning to hold an advisory committee meeting to discuss the application.
If approved, the avutometinib-defactinib combination would become the first treatment specifically indicated for low-grade serous ovarian cancer and the first treatment for KRAS-mutant ovarian cancer.
The application was based on data presented at a conference in October from the Phase II RAMP 201 trial, which demonstrated a confirmed overall response rate of 44 percent and median duration of response of 31.3 months in KRAS-mutant low-grade serous ovarian cancer patients on avutometinib and defactinib. Median progression-free survival in the KRAS-mutant group was 22 months. The application also includes data from low-grade serous ovarian cancer patients in the Phase I FRAME trial.
Verastem is currently enrolling recurrent low-grade serous ovarian cancer patients regardless of KRAS mutation status in a Phase III confirmatory trial of the avutometinib-defactinib combination. The trial will compare the treatment against standard chemotherapy or hormonal therapy.