FDA Approves Replimune’s Melanoma Drug Tudriqev
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- FDA granted accelerated approval to Replimune's RP1 for advanced melanoma, now marketed as Tudriqev, following an advisory panel's recent vote in favor.
- Replimune secured regulatory clearance for Tudriqev after its application was previously rejected twice, overcoming significant regulatory hurdles.
- FDA advisers voted last week to support the drug despite staff concerns about the design and conduct of Replimune’s pivotal clinical trial.
- Tudriqev will carry a list price of $450,000 per treatment course before rebates and discounts, Replimune confirmed.
Why it matters: Patients gain access to a new melanoma therapy after repeated rejections, while Replimune avoids a potential setback that could have derailed its future; the $450,000 price tag underscores ongoing pressure on payers for high-cost oncology drugs with marginal trial data.
