Posted by Michael Wonder on 31 Oct 2024
Verastem Oncology completes rolling NDA submission to the FDA for avutometinib plus defactinib as a treatment for recurrent KRAS mutant low grade serous ovarian cancer
31 October 2024 - Company seeking accelerated approval and priority review of its new drug application submission in patients with KRAS mutant low grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid 2025.
Verastem Oncology today announced that the Company has completed its rolling new drug application to the US FDA for the investigational and 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, who received at least one prior systemic therapy.
