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Second FDA Rejection for Replimune's Melanoma Drug
10 Apr
Summary
- FDA denied Replimune's skin cancer drug for advanced melanoma.
- Regulators cited insufficient data for substantial evidence of effectiveness.
- Replimune shares dropped over 19% following the decision.
The US Food and Drug Administration has once again denied Replimune Group Inc.'s application for its skin cancer treatment intended for advanced melanoma.
The regulatory agency cited that the provided data was insufficient to conclude substantial evidence of the drug's effectiveness. This marks the second rejection for Replimune's combination immunotherapy treatment.
Following the FDA's decision, Replimune shares experienced a significant decline, dropping over 19% before trading was temporarily halted. This denial comes after an initial rejection in July, when the FDA raised concerns about the trial design and patient population.
Replimune had resubmitted its application with additional information, seeking approval based on a single-arm clinical trial. However, the FDA indicated that such studies, lacking a control group, are not typically recommended for approval, especially after the departure of a key FDA official who had voiced similar criticisms.
Melanoma, the most serious form of skin cancer, saw an estimated 330,000 new cases and nearly 60,000 deaths globally in 2022, highlighting the ongoing need for effective treatments.
