On Monday, the FDA accepted for review the New Drug Application under the accelerated approval pathway for Verastem Oncology's (NASDAQ:VSTM) avutometinib.
The company seeks approval of avutometinib in combination with defactinib for adult patients with recurrent low-grade serous ovarian cancer (LGSOC) who received at least one prior systemic therapy and have a KRAS mutation.
The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act action date of June 30, 2025.
In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
The filing was based on a primary Phase 2 RAMP 201 clinical trial analysis.
The results were presented in an oral presentation at the International Gynecologic Cancer Society Annual Global Meeting in October 2024 and demonstrated that the combination of avutometinib plus defactinib resulted in a substantial overall response rate confirmed by a blinded independent central review, with responses that were typically durable, and that the combination was generally well-tolerated in patients with recurrent KRAS mutant LGSOC.
The NDA also includes supportive data from the FRAME Phase 1 trial, the first study conducted with the combination therapy in recurrent LGSOC.
The company is currently enrolling patients with recurrent LGSOC regardless of KRAS mutation status for RAMP 301, an international Phase 3 trial.
The trial will serve as a confirmatory study for the initial indication and has the potential to support an expanded indication regardless of KRAS mutation status.
In May, Verastem Oncology revealed initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel as a first-line treatment for patients with metastatic pancreatic cancer.
Price Action: VSTM stock is up 26.4% at $4.64 at last check Tuesday.
- Comstock Expands Global Reach With Renewable Fuel Deal In Pakistan: Details
Photo: Shutterstock
