Favorable Outcome of FDA’s CTGTAC Meeting for RP1 in Advanced Melanoma Announced
“We are encouraged by today’s outcome and would like to thank the committee for its thoughtful discussion of the IGNYTE data,” said Sushil Patel, Ph.D., CEO of Replimune. “We are grateful to the patients and physicians who took the time to speak today and so clearly articulate the high unmet need in advanced melanoma and importance of new treatment options such as RP1 for the community. This is an important step forward for patients with advanced melanoma who have progressed on anti-PD-1 therapy. We look forward to continuing to work with the FDA as it completes its review of the BLA ahead of the action date.”
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