Why the FDA rejected a ‘breakthrough’ melanoma drug
The FDA has twice rejected RP1, a 'breakthrough' melanoma drug, despite its promising results in clinical trials, leaving researchers and developers puzzled. RP1, an oncolytic immunotherapy, showed a 33% success rate in treating treatment-resistant advanced melanoma when combined with nivolumab.
The FDA has rejected RP1, a melanoma drug, twice, despite its promising results in clinical trials. RP1 is an oncolytic immunotherapy made of an engineered herpesvirus that is injected directly into melanoma tumors, causing cancer cells to burst and triggering the immune system to kill similar cancer cells. Approximately 110,000 new melanoma cases are diagnosed annually in the U.S. The drug's phase 1/2 clinical trial, IGNYTE, showed that nearly 33% of patients with treatment-resistant advanced melanoma saw their condition improve with RP1 and nivolumab. The FDA initially gave RP1 'breakthrough therapy' designation, but the rejection has puzzled researchers and developers. Replimune CEO Sushil Patel expressed concern over the FDA's behavior, stating it has put the company in a difficult position.
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