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The agency had twice rejected the engineered viral therapy over concerns about the design of Replimune's clinical trial
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Replimune Group received accelerated approval from the Food and Drug Administration for its melanoma drug Tudriqev on Thursday, ending a regulatory battle that stretched across three submissions and two rejections.
The FDA approved Tudriqev — known generically as vusolimogene oderparepvec-wtpg — in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma whose disease progressed after treatment with a PD-1-blocking immunotherapy regimen. Replimune has set the drug's list price at $450,000 for a full course of treatment, not accounting for rebates and discounts, according to STAT News.
