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FDA Panel Backs Skin Cancer Drug Trial
31 Jul
Summary
- Advisers backed Replimune's skin cancer drug trial results.
- FDA previously rejected the drug application twice.
- The drug is for advanced melanoma, a severe skin cancer.
A panel of external advisors to the U.S. Food and Drug Administration voted on Thursday to support the findings from a clinical trial involving Replimune's investigational drug. This marks a significant step after the FDA had previously declined to approve the drug, citing concerns about the study's design.
In April, the health agency rejected an initial application for the drug, requesting more data from a well-controlled trial to demonstrate its effectiveness. Replimune is seeking approval for its drug, RP1, in combination with Bristol Myers Squibb's immunotherapy, Opdivo, for patients with advanced melanoma. This aggressive form of skin cancer presents a significant treatment challenge.
