Replimune’s RP-1 for unresectable metastatic cutaneous melanoma cleared an FDA Cellular, Tissue, and Gene Therapies Advisory Committee hurdle, after the panel voted 10-3 that the Ignyte phase II efficacy results are evaluable and clinically meaningful. The FDA is now set to decide on RP-1 by Aug. 2, following two prior complete response letters that previously stalled the resubmission.
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