BIOBRIEF
The agency approved Replimune's RP1 (brand name Tudriqev) on Thursday despite staff concerns about the trial's design; the drug still must clear a confirmatory study.
The FDA on Thursday granted accelerated approval to Replimune's RP1, a modified herpes virus paired with the PD-1 inhibitor nivolumab and to be sold as Tudriqev, for adults with advanced melanoma, meaning skin cancer that has spread beyond the original site. It is the drug's third attempt at FDA approval; the first two were rejected.
The approval is conditional, not a final verdict. Accelerated approval is a faster pathway for serious diseases with limited options; the drug can stay on the market only if a required follow-up study confirms that patients actually live longer or better. Replimune said it will run that confirmatory trial, and the agency can withdraw the drug if the study fails.
The FDA's own reviewers had warned that the company's main trial was small and unevenly randomized, with gaps in how side effects and responses were measured, but the Cellular, Tissue and Gene Therapies Advisory Committee voted in favor the week of July 27, saying the efficacy signal and unmet need justified acting now. That came months after a Complete Response Letter for BLA 125827 on April 10, 2026, the latest turn in a back-and-forth that included an earlier refusal-to-file and rejection cycle.
Replimune has not yet disclosed Tudriqev's wholesale price. The company's accelerated-approval announcement confirms the combination and indication but leaves the access question open.