STAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and more
An FDA advisory panel recommended use of an experimental Replimune treatment for advanced melanoma that the agency has rejected twice
The U.S. Food and Drug Administration (FDA) advisory panel has voted 10-to-3 in favor of recommending an experimental Replimune treatment for advanced melanoma, STAT reports. The recommendation hinges on the fact that Novo Nordisk, the pharmaceutical company behind RP1, an engineered viral immunotherapy, has presented sufficient data for the FDA to review.
This decision, which comes after two previous rejections in 2022 and April 2023, could be seen as an indication of the FDA's new approach to assessing investigational drugs under the current administration. The approval of RP1 may signal a more permissive stance by the FDA, potentially setting a precedent for future evaluations of innovative therapies.
Written by urgent.news from STAT News's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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