FDA blocked melanoma drug as confusion reigned under Makary
Summary
The U.S. Food and Drug Administration (FDA) decided not to approve a new melanoma drug called RP1, which showed promise in clinical trials by helping some patients live longer. This decision happened under FDA Commissioner Marty Makary, who has changed how the agency operates and has faced criticism for mixing politics with science.Key Facts
- RP1 is a new treatment for melanoma, a serious type of skin cancer.
- In a clinical trial, about one-third of 140 patients saw their tumors shrink or disappear.
- The FDA rejected the drug’s accelerated approval because the company did not follow the agency's suggested changes to the trial plan.
- Melanoma causes about 8,500 deaths yearly in the U.S., with 112,000 new cases expected.
- RP1 is a genetically engineered virus that kills cancer cells and helps the immune system fight tumors.
- FDA Commissioner Marty Makary has changed the agency’s culture, leading to uncertainty about how decisions are made.
- Makary accused the drug maker, Replimune, of "corruption" and said he works for the public, not the company.
- Makary resigned recently, and his leadership raised concerns about mixing politics and science in drug approvals.
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