FDA Accepts RP1 BLA Resubmission for Advanced Melanoma

A resubmission of the biologics license application (BLA) for vusolimogene oderparepvec (RP1) in combination with nivolumab (Opdivo) for patients with advanced melanoma has been accepted by the FDA, according to a press release from Replimune.

A class 1 response rate of August 2, 2026, has been set, and the FDA noted for the company to expect an advisory committee for later in July. Upon the resubmission, an accelerated approval is sought, based on previous data from the phase 1/2 IGNYTE trial (NCT03767348) for those with confirmed progression on anti-PD–1 containing regimen.

“We are pleased that the FDA has demonstrated urgency in reconsidering the RP1 BLA with an expeditious action date in recognition of the significant unmet need for [patients with] advanced melanoma patients and support from the broader melanoma community,” Sushil Patel, PhD, chief executive officer of Replimune, said in a press release. “We look forward to a productive scientific and clinical discussion on the risk/benefit profile of RP1 in this difficult to treat setting.”

Reference

Replimune announces FDA acceptance of RP1 biologics license application resubmission for advanced melanoma. News release. June 26, 2026. Accessed June 29, 2026. https://tinyurl.com/4sdytzn4