Replimune Group announced that the FDA has accepted its Biologics License Application (BLA) resubmission for RP1, the company’s lead oncolytic immunotherapy product candidate, for the treatment of advanced melanoma. The resubmission follows the FDA’s prior request for additional information after a Complete Response Letter (CRL) was issued earlier in 2025.
According to Replimune, the resubmitted BLA includes supplemental data addressing manufacturing and procedural points raised in the CRL. The clinical components of the submission are supported by results from the CERPASS and IGNYTE trials, which evaluated RP1 in combination with nivolumab in patients with cutaneous melanoma that progressed on prior immune checkpoint inhibitor therapy.
The FDA has accepted the BLA as a complete response and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 2026. The agency did not indicate the need for an advisory committee meeting to discuss the application.
If approved, RP1 would represent the first oncolytic immunotherapy for melanoma designed to selectively replicate in tumor cells, stimulate an immune response, and work synergistically with PD-1 blockade. Replimune stated that it is preparing commercial and manufacturing readiness activities in alignment with the PDUFA timeline.
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