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MAY 9, 2025

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


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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