Replimune lacks clear pathway in melanoma after FDA meeting

US biotech Replimune (Nasdaq: REPL) said a meeting with the American medicines regulator has not yet resolved questions around the path forward for its lead therapy RP1 (vusolimogene oderparepvec) in advanced melanoma.

The company met with the Food and Drug Administration (FDA) on September 16 to review its complete response letter, which in July rejected the firm’s application for accelerated approval of RP1 in combination with Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab). Replimune said it is reviewing the agency’s feedback but no clear regulatory route has been established.

Chief executive Sushil Patel said, “The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial. We remain committed to working with the FDA to determine an expeditious path forward for RP1.”