Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA
Frank Vinluan / medcitynews - Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than four months. The FDA nod for Replimune’s oncolytic viral therapy, Tudriqev,…
AI Summary: After two previous turns in the penalty box, the FDA granted accelerated approval to Replimune’s oncolytic immunotherapy Tudriqev (RP1) in combination with nivolumab for advanced melanoma. The decision follows a favorable advisory committee outcome and positions a once-spurned viral-based therapy back into the clinic as a new option for patients with limited choices.
- Clinical community reaction and rollout: experts and training (4)
- Regulatory comeback: FDA approves Tudriqev after two rejections (4)
- Replimune announcements and company leadership reactions (3)
- All Other Stories
Clinical community reaction and rollout: experts and training
Regulatory comeback: FDA approves Tudriqev after two rejections
Replimune announcements and company leadership reactions
All Other Stories
Blog Post
The FDA has granted accelerated approval to Replimune’s oncolytic immunotherapy TUDRIQEV (vusolimogene oderparepvec, RP1) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed following treatment. The decision, announced Aug. 6, 2026, follows two prior FDA rejections and a favorable Cellular, Tissue, and Gene Therapies Advisory Committee vote (10–3 on July 30) that the trial results were evaluable and clinically meaningful. Replimune has thanked patients, families and clinicians who participated in its trials, and the approval returns a once-spurned viral-based therapy to the clinic as an additional option for patients — positioned by some observers as a more convenient alternative to an existing cell therapy in this setting.