FDA Accepts BLA for RP1 and Opdivo in Melanoma
The FDA has accepted and granted priority review to the biologics license application (BLA) seeking the approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma who have received prior treatment with a PD-1 inhibitor–containing regimen
The BLA has been assigned a target action date of July 22, 2025, under the Prescription Drug User Fee Act. The FDA does not anticipate holding an advisory committee meeting to discuss the application.
“There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti–PD-1–containing regimen,” Sushil Patel, PhD, chief executive officer of Replimune, stated in a news release. “The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application.”
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