FDA Grants Accelerated Approval to Avmapki Fakzynja Co-pack for Some Ovarian Cancers

The FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem) for adult patients with KRAS-mutated, recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

Efficacy was evaluated in RAMP-201 (ClinicalTrials.gov Identifier: NCT04625270), a multicenter, open-label trial that included 57 adult patients with measurable KRAS-mutated, recurrent LGSOC. Patients were required to have received at least one