FDA Rejects Replimune’s Advanced Skin Cancer Drug Due to Insufficient Data
- Food and Drug Administration (FDA) declined to approve vusolimogene oderparepvec, referred to as RP1, for the treatment of advanced melanoma on April 10, 2026.
- The immunotherapy, developed by Replimune, was under review for patients with advanced skin cancer.
- In a Complete Response Letter (CRL), the FDA cited specific deficiencies related to the findings submitted by Replimune.
The U.S. Food and Drug Administration (FDA) declined to approve vusolimogene oderparepvec, referred to as RP1, for the treatment of advanced melanoma on April 10, 2026.
The immunotherapy, developed by Replimune, was under review for patients with advanced skin cancer. The treatment was intended for use in combination with nivolumab, a cancer drug produced by Bristol Myers Squibb known as Opdivo.
FDA Findings and Data Deficiencies
In a Complete Response Letter (CRL), the FDA cited specific deficiencies related to the findings submitted by Replimune. The agency indicated that the provided data were insufficient to conclude substantial evidence of effectiveness
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According to the CRL, the FDA specifically noted a lack of duration of response (DOR) data as a factor in the decision to withhold approval.
Regulatory History and Market Response
This decision marks the second time the FDA has rejected the melanoma drug. The agency had previously spurned the treatment for the same indication.
Following the announcement of the second rejection on April 10, 2026, Replimune’s stock price experienced a significant decline.