FDA Blocked Melanoma Drug as Confusion Reigned Under Makary

A third of patients in a clinical trial had tumors shrink while taking a genetically engineered treatment known as RP1.

By: Arthur Allen

Outlets: KFF Health News

Published: May 15, 2026

Words: 1,514

Last Updated: 2 months, 1 week ago

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The FDA’s recent decision to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat melanoma and patients who saw that the drug had prolonged the lives of a third of the participants in a clinical trial.

“It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.

“This is life or death for maybe 2,000 patients,” added …

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