FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
read at STAT ↗RegulatoryNeutral
STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma.
The panel will decide if the company has gathered enough data to merit accelerated approval. While the agency often follows the advisory committee's recommendations, it is not obligated to do so.
RP1 was previously rejected in April under former FDA leaders, so the outcome may signal how the new administration weighs the benefits and risks of investigational drugs.
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This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: FDA expert committee votes in favor of Replimune’s melanoma treatment”
read at STAT ↗576 words · retrieved Jul 30
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