The U.S. Food and Drug Administration (FDA) has accepted Replimune’s (NASDAQ: REPL) resubmitted Biologics License Application (BLA) for RP1, its oncolytic immunotherapy candidate. The application seeks approval for RP1 in combination with nivolumab to treat patients with advanced melanoma whose disease has progressed following anti-PD-1 therapy.
The agency has classified the resubmission as a Class II review and set a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026.
This development follows the FDA’s issuance of a Complete Response Letter (CRL) in July 2025. Replimune stated that the new submission includes additional information, data, and analyses to address the agency’s previous feedback. The FDA now considers the filing a complete response to the CRL, allowing the formal review process to begin.
Sushil Patel, CEO of Replimune, noted that the combination therapy addresses a patient population with few available treatment options. He added that the company will work with the FDA to expedite the review.
RP1, also known as vusolimogene oderparepvec, is a genetically engineered herpes simplex virus designed to selectively destroy cancer cells and stimulate a broad, systemic anti-tumor immune response.
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