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What happened at FDA? Replimune approval raises questions
Summary by The Cancer Letter
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What happened at FDA? Replimune approval raises questions
Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA 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. This episode is available on Spotify, Apple Podcasts, and Youtube. The approval and th…
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