FDA Accepts Replimune’s Resubmitted BLA for RP1 in Advanced Melanoma Ahead of PDUFA Date April 2026
Replimune Group, Inc. has received significant news regarding its candidate RP1, a treatment for advanced melanoma. The U.S. Food and Drug Administration (FDA) accepted the resubmitted Biologics License Application (BLA) for RP1 combined with nivolumab. This decision comes as Replimune aims to address treatment options for patients progressing on anti-PD-1 therapies.
FDA Acceptance of BLA Resubmission for RP1
The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date for this combined therapy, set for April 10, 2026. This timing falls under a Class II resubmission timeline, indicating an expedited review process.
Details of the Resubmission
Replimune’s resubmission includes comprehensive additional data, information, and analyses aimed at responding to the FDA’s previous concerns. This process follows a complete response letter issued by the FDA in July 2025. The acceptance of this resubmission is a positive step for Replimune and its stakeholders.
Understanding the Role of RP1 and Nivolumab
RP1 is designed to work alongside nivolumab, providing new hope for advanced melanoma patients who have limited options after progressing on anti-PD-1 therapy. The use of RP1, based on a genetically modified strain of the herpes simplex virus, is intended to enhance anti-tumor immune responses and maximize tumor destruction.
- Therapy Combination: RP1 + Nivolumab
- Target Patient Group: Individuals with advanced melanoma
- FDA PDUFA Date: April 10, 2026
- Prior FDA Letter: Complete response issued in July 2025
CEO Statement
Sushil Patel, Ph.D., CEO of Replimune, expressed optimism regarding the FDA’s acceptance. He highlighted the need for effective treatment alternatives for patients facing advanced melanoma challenges.
Future Outlook
The recent FDA action is seen as a crucial milestone in Replimune’s drug development journey. As the company continues to gather data and respond to regulatory feedback, it aims to facilitate timely industry collaborations to benefit patients.
For further updates, keep an eye on news from Emegypt regarding Replimune’s ongoing efforts in cancer treatment innovation.
