STAT+: Tracking the FDA expert review of Replimune’s melanoma treatment
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- Replimune's experimental melanoma treatment RP1 went before the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee on Thursday to evaluate whether the biotech has collected sufficient data to support accelerated approval.
- The FDA rejected RP1 in April under former leaders Marty Makary and Vinay Prasad, making Thursday's advisory committee meeting a potential reversal under new FDA leadership.
- Investors interpreted the FDA's decision to convene the advisory committee as a sign of new leniency toward the drug, bidding the stock accordingly.
- STAT reported that the original resistance to RP1 came from the FDA's career staff, not political leadership, complicating the narrative of a policy reversal under new leaders.
- The FDA typically follows its advisory panel recommendations but is not bound by them, meaning the panel's vote serves as guidance rather than a binding decision on approval.
Why it matters: Replimune's RP1 melanoma drug faces a second look at the FDA after an April rejection, and investors have priced in potential leniency from new leadership — but STAT's reporting that career staff drove the original rejection means the panel outcome may not signal as dramatic a policy shift as the market expects.
