Verastem Oncology, a biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for their AVMAPKI™ FAKZYNJA™ CO-PACK. This innovative treatment, which combines avutometinib capsules and defactinib tablets, is the first-ever FDA-approved therapy for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have previously undergone systemic therapy. The approval, which came ahead of the scheduled June 30, 2025, PDUFA action date, is based on results from the Phase 2 RAMP 201 study, which demonstrated a 44% overall response rate. The AVMAPKI FAKZYNJA CO-PACK will be available by prescription as a convenient oral combination in the U.S. Continued approval will depend on further confirmation of clinical benefits in a subsequent trial.
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