Replimune (NASDAQ:REPL) announced on Tuesday that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding its marketing application for its lead asset, RP1, declining to approve it as part of a combination regimen for melanoma, a type of skin cancer.
In January, the FDA granted priority review for the company’s Biologics License Application targeted at patients with advanced melanoma as a treatment in combination with nivolumab, marketed by Bristol Myers (BMY) as Opdivo.
The BLA, backed mainly by data from the company’s IGNYTE trial, was granted a target action date of July 22.
As reasons for the rejection, the agency has cited that IGNYTE was not an adequate and well-controlled clinical trial that could demonstrate RP1’s efficacy and raised concerns over certain components related to the company’s confirmatory trial design.
Replimune (NASDAQ:REPL) said it would seek discussions with the FDA via a Type A meeting to secure a potential approval for RP1 under the agency’s accelerated approval pathway.
