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
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