> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Verastem Oncology NDA for Rare Ovarian Cancer
- URL: https://www.fdaweb.com/verastem-oncology-nda-for-rare-ovarian-cancer/
- Published: 2024-10-31T12:00:00.000Z
- Updated: 2026-09-14T14:45:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158103

Verastem Oncology has completed a rolling NDA for the potential first-in-class combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral selective FAK inhibitor, for adults with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy. The company says it is seeking accelerated approval for the combination therapy.

The submission is based on data from the Phase 2 RAMP 201 study that demonstrated a confirmed overall response rate of 44%, a median progression-free survival of 22 months, and a disease control rate at six months of 70% in the target population, according to the company. The NDA submission also includes supportive data from the FRAME Phase 1 trial.

The company says it is currently enrolling patients with recurrent LGSOC regardless of KRAS mutation status in RAMP 301, an international Phase 3 trial that will serve as a confirmatory study for the initial indication. The study may also support an expanded indication regardless of KRAS mutation status, it adds.