Robert F. Kennedy Jr. doesn’t like our criticism of the Food and Drug Administration’s rejection of Replimune’s life-saving drug for metastatic melanoma. But the Health and Human Services Secretary’s statements at a House hearing [on April 16, 2026] were as bewildering as the FDA rejection.
“[T]he career scientists who looked at that drug said it was not effective,” he said. That isn’t true. The initial panel that reviewed Replimune’s RP1 recommended approval. It was overruled by FDA biologics chief Vinay Prasad.
[T]he FDA last fall agreed to reconsider RP1 and selected a second panel to eliminate what it called “bias.” … So [Prasad] tapped new reviewers who shared his bias against the drug. But even these reviewers didn’t say the drug wasn’t effective.
The FDA rejection letter instead said it is unclear whether the drug was effective based on contrived reasoning that Mr. Kennedy parroted: “[A]ll the people who were tested also received a chemotherapy drug, so we don’t know what the effect was,” Mr. Kennedy said. Fact-check: No patients in the trial received chemotherapy.
…
“I have patients who have been treated with this drug that are still alive today who would otherwise be dead,” [said Anna Pavlick, a physician who has studied melanoma for 25 years.]
This is an excerpt. Read the original post here
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