FDA grants accelerated approval to Replimune's melanoma drug RP1.
The U.S. FDA has granted accelerated approval to Replimune's drug RP1 (Tudriqev) for advanced melanoma on a national level. The approval was based on a single trial for which FDA staff had expressed concerns. A confirmatory trial is ongoing, and the drug had been rejected twice previously.
Why it matters
This provides a new treatment option for patients with advanced melanoma, for whom new options are very limited.
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