FDA grants accelerated approval to Replimune's melanoma therapy Tudriqev
The FDA has issued accelerated approval for Replimune’s advanced melanoma drug RP1, to be sold as Tudriqev, after advisory board support.
Replimune secured FDA clearance for its experimental melanoma treatment, RP1, which will be marketed under the name Tudriqev. The agency granted accelerated approval following a favorable vote by its advisers, despite internal staff concerns about the trial’s design. Regulators concluded that the drug shows enough efficacy to address the urgent need for new options in advanced melanoma. Pricing details for Tudriqev have not yet been released by the company.
Why it matters
It introduces a new FDA-approved option for advanced melanoma, a cancer with few effective treatments.
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FDAReplimunemelanomaaccelerated approvalRP1Tudriqevclinical trialdrug pricing