Sushil Patel

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FDA weighs Replimune's melanoma immunotherapy RP1

Leads Replimune into its first commercial launch after winning FDA approval for Tudriqev on the company's third submission.

The FDA granted accelerated approval on August 6 to Replimune's tumor-injected virus therapy, now sold as Tudriqev, after rejecting it twice. An advisory panel had voted 10-3 on July 30 that the trial data were reliable enough to support approval, despite FDA staff's earlier doubts.

Updated Aug 8

Notable Quotes

Patel has said the durable responses seen in IGNYTE reflect a real benefit for patients who have run out of options.

from FDA weighs Replimune's melanoma immunotherapy RP1 · Updated Aug 8

"We are deeply grateful to the melanoma community, including patients and investigators who participated in the clinical trial, for their tremendous support of this approval."

from FDA weighs Replimune's melanoma immunotherapy RP1 · Updated Aug 8