FDA
FDA issues second complete response letter for RP1 in advanced melanoma
FDA has issued a Complete Response Letter (CRL) to Replimune Group, declining to approve the company’s biologics license application for RP1 in combination with nivolumab for the treatment of advanced melanoma. The decision means the application cannot be approved in its current form.
RP1 (vusolimogene oderparepvec) is an investigational oncolytic immunotherapy that previously received breakthrough therapy designation. In its announcement, Replimune said it disagrees with the FDA’s assessment that the submitted data were insufficient to demonstrate effectiveness. Results from the phase 2 IGNYTE trial showed a 34% objective response rate and a median duration of response of 24.8 months in patients whose disease had progressed on prior anti–PD-1 therapy, with a favorable safety profile.
According to the company, the CRL followed a review by a different FDA team than the one involved in earlier interactions, and Replimune expressed concern about what it described as inconsistent regulatory communication. The company warned that, without a clear path to accelerated approval, continued development of RP1 for advanced melanoma may not be viable.
“It is deeply disappointing that the FDA has not exercised regulatory flexibility to meet patients’ needs given the data supporting strong efficacy and the favorable safety profile,” said Sushil Patel, PhD, chief executive officer of Replimune. “A treatment desperately needed by patients will not be available. Not because the medicine failed. Because the system did.”