Why the FDA rejected a ‘breakthrough’ melanoma drug

A new drug called RP1 offers hope for patients with skin cancer that doesn’t respond to traditional treatments. This drug, an oncolytic immunotherapy, uses a modified virus to attack cancer cells and stimulate the immune system. Despite promising results in clinical trials, where it improved conditions for nearly 33% of patients with advanced melanoma, the FDA has twice declined to approve it, leaving researchers and developers puzzled. Melanoma is a serious skin cancer, with 110,000 new cases annually in the U.S. While early-stage melanoma is highly treatable, advanced cases have a much lower survival rate. RP1 could provide a crucial new option for those with treatment-resistant melanoma, but its approval remains uncertain, raising concerns about the FDA’s decision-making process. QUESTION: Why do you think the FDA might be hesitant to approve a drug like RP1 despite its promising trial results?