Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC). Avutometinib is an oral rapidly accelerated fibrosarcoma/mitogen-activated protein kinase kinase clamp while defactinib is an oral selective focal adhesion kinase inhibitor. The gold standard of business intelligence.
The NDA was submitted under the FDA’s accelerated approval pathway, with Verastem requesting a priority review. If the FDA grants priority review, a decision on the NDA could come within six months after the 60-day filing period. Verastem initiated the rolling NDA submission in May 2024, based on the preliminary results from the Phase II RAMP 201 study.
The two-part, multicentre, adaptive, parallel cohort, randomised, open-label trial assessed the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The study reported an overall response rate of 44%, median progression-free survival of 22 months,.