Posted by Michael Wonder on 31 Dec 2024
Verastem Oncology announces FDA acceptance and priority review of new drug application for avutometinib in combination with defactinib for the treatment of recurrent KRAS mutant low grade serous ovarian cancer
30 December 2024 - PDUFA target action date is 30 June 2025.
Verastem Oncology today announced that the US FDA has accepted for review the new drug application under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer, who received at least one prior systemic therapy and have a KRAS mutation.
