July 30 (Reuters) – A panel of outside advisers to the US Food and Drug Administration voted to back results from a trial studying Replimune’s drug for a type of skin cancer in a meeting on Thursday.
This comes after the FDA declined to approve the drug in April, citing reliance on a single-arm study without a control group, and sought more data from a well-controlled trial demonstrating adequate evidence of the drug’s effectiveness.
The health agency had also rejected an initial application last year.
Replimune is seeking approval for RP1 in combination with Bristol Myers Squibb’s immunotherapy Opdivo for the treatment of advanced melanoma, a highly aggressive form of skin cancer.
(Reporting by Puyaan Singh in Bengaluru; Editing by Shailesh Kuber)
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