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STAT+: FDA approves Replimune melanoma drug previously rejected twice
The Food and Drug Administration has cleared Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment.
The FDA’s decision to grant accelerated approval to the drug, which is called RP1 and will be marketed as Tudriqev, came after its advisers last week voted in support of the treatment. Even though FDA staff expressed concerns about the design and conduct of Replimune’s key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.
Replimune has not yet disclosed Tudriqev’s price.
The Food and Drug Administration has cleared Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment.
The FDA’s decision to grant accelerated approval to the drug, which is called RP1 and will be marketed as Tudriqev, came after its advisers last week voted in support of the treatment. Even though FDA staff expressed concerns about the design and conduct of Replimune’s key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.
Replimune has not yet disclosed Tudriqev’s price.