USFDAJun 29, 2026, 08:17 AM
Replimune RP1 BLA Resubmission Accepted; FDA Advisory Committee in July
AI Summary
Replimune Group, Inc. provided updates on its lead product candidate, RP1, for advanced melanoma, including the FDA's second Complete Response Letter (CRL) issued on April 10, 2026. Following collaborative communications, the company and FDA aligned on a path forward, leading to the acceptance of a BLA resubmission on June 26, 2026, with a target action date of August 2, 2026. The FDA also plans to convene an advisory committee meeting in late July 2026. The company also detailed progress on its RP2 clinical trials for metastatic uveal melanoma and other non-melanoma skin cancers, while noting that RP3 development is currently halted.
Key Highlights
- FDA issued second CRL for RP1 BLA for advanced melanoma on April 10, 2026.
- Replimune and FDA aligned on path forward for RP1 BLA resubmission, accepted June 26, 2026.
- FDA set target action date of August 2, 2026, for RP1 BLA resubmission.
- FDA will convene an advisory committee meeting in late July 2026 for RP1 BLA.
- RP1 IGNYTE trial showed 32.9% ORR and 33.7 months median DOR in anti-PD-1 failed melanoma.
- RP2 REVEAL study is a randomized Phase 2/3 trial enrolling ~280 mUM patients.
- RP2 monotherapy/combo with nivolumab showed 29.4% ORR in metastatic uveal melanoma.
- Development of RP3 product candidate is currently not being pursued due to prioritization.
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