Replimune submits RP1 BLA to FDA, receives breakthrough therapy designation

Replimune (REPL) announced that it has submitted a biologics license application, or BLA, to the FDA for RP1 in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the accelerated approval pathway. The company also announced that the FDA has granted breakthrough therapy designation to RP1 in combination with nivolumab in the same setting.