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FDA Finally OKs Twice-Rejected Melanoma Drug
The accelerated approval hinges on a confirmatory Phase 3 trial after a single-arm study found about 25% of patients responded.
- On Thursday, the Food and Drug Administration granted accelerated approval to Replimune's Tudriqev in combination with Opdivo for adult patients with unresectable or metastatic melanoma who progressed on prior anti-PD-1-based therapy.
- The approval follows two previous rejections, a third resubmission, and a 10-3 favorable vote from the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee on July 30, 2026.
- Engineered as an oncolytic virus, Tudriqev destroys cancer cells while triggering immune responses; clinical trial data showed a 24% objective response rate with a median response duration of 14.1 months.
- Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research , said the milestone gives oncologists a "meaningful new tool" and more patients a "fighting chance."
- Continued licensure depends on the success of an ongoing Phase 3 trial, while Leerink Partners analyst Daina Graybosch predicted the drug could achieve $618 million in peak annual sales.
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14 Articles
14 Articles
Twice Rejected Replimune Cancer Drug Finally Gets FDA Approval
·New York, United States
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Total News Sources14
Leaning Left0Leaning Right1Center10Last UpdatedBias Distribution91% Center
Bias Distribution
- 91% of the sources are Center
91% Center
C 91%
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