FDA clears Replimune melanoma drug RP1 for continued testing

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

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.

The list price of Tudriqev will be $450,000 per course of therapy before customary rebates and discounts, Replimune said.

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