FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee

Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

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FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

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Jacquelyn Cobb
Managing Editor
Paul Goldberg
Editor & Publisher
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