FDA Acceptance of BLA Resubmission Puts Replimune in the Spotlight
The U.S. Food and Drug Administration has accepted Replimune Group’s Biologics License Application (BLA) resubmission for RP1, in combination with nivolumab, targeting patients with advanced melanoma who have already progressed after PD-1 therapy. A Prescription Drug User Fee Act (PDUFA) action date has been scheduled for April 10, 2026, positioning Replimune at the center of a high-stakes regulatory review.
PDUFA Date Announcement Raises Expectations for Advanced Melanoma Therapy
This acceptance follows several months of work addressing prior agency feedback. The resubmission, which now includes new data and analyses, is classified as a complete response to the earlier FDA letter from July 2025. For patients facing advanced melanoma with limited treatment options, this review marks a possible inflection point, especially given RP1’s mechanism aiming to spark immune activity where other regimens fall short.
Key Details: Timeline and Scope of the Regulatory Process
| Event | Date | Details |
|---|---|---|
| FDA BLA Resubmission Accepted | Oct. 20, 2025 | Complete response to July 2025 FDA feedback; classified as Class II resubmission |
| PDUFA Decision Date | April 10, 2026 | Potential for U.S. commercial approval of RP1 + nivolumab |
Product Profile: RP1 Designed to Ignite Systemic Immune Response
RP1, also known as vusolimogene oderparepvec, leverages a genetically modified herpes simplex virus backbone armed with a fusogenic protein (GALV-GP R-) and GM-CSF. The result is targeted tumor destruction paired with the activation of an immune response intended to address advanced disease. Replimune’s platform aims for versatility, as these therapies could be combined with other established or emerging treatments in oncology.
Strategic Considerations and Sector Impact: Pivotal Test Ahead
Investors and healthcare professionals now turn their attention to several key questions: Can RP1 show durable benefit where PD-1 regimens have failed? How will the FDA weigh new data against the need for effective options in refractory melanoma? With an approval, Replimune could unlock new avenues for oncolytic immunotherapies in broader indications, given its platform’s synergy with various cancer treatments.
Takeaway: All Eyes on April 2026 for Advanced Melanoma Progress
The acceptance of Replimune’s resubmitted BLA and the firm April 2026 decision date mean that both patients and investors now have a clear timeline. While regulatory risks remain—as the process is shaped by new analyses and agency priorities—this marks one of the most significant regulatory moments for the company to date. Anyone interested in the future of immunotherapy for melanoma will want to watch the months ahead closely.
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