Posted by Michael Wonder on 25 May 2024
Verastem Oncology announces the initiation of a rolling submission of NDA to FDA seeking accelerated approval of avutometinib and defactinib combination for the treatment of adult patients with recurrent KRAS mutant low grade serous ovarian cancer
24 May 2024 - Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of follow-up, in the second half of 2024.
Verastem Oncology today announced that it has initiated the rolling submission of a New Drug Application to the US FDA seeking accelerated approval of the combination of avutometinib, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, for adult patients with recurrent KRAS mutant low-grade serous ovarian cancer, who received at least one prior systemic therapy.
