0720 GMT - Roche was dealt a setback by a U.S. Food and Drug Administration advisory committee, which voted against approval of the Swiss pharmaceutical company's Columvi lymphoma drug, Vontobel's Stefan Schneider says in a research note. The FDA's Oncologic Drugs Advisory Committee on Tuesday voted 8 to 1 against Columvi's approval as a second-line lymphoma treatment--for patients who aren't eligible for standard treatment--, arguing it needed more data as patients in a late-stage trial weren't representative of the U.S. patient population. The committee issues nonbinding recommendations, but the FDA--due to decide on Columvi by July--generally follows them, Vontobel says. The prospect of Roche getting approval for Columvi as a third-line treatment could be at risk as well, the analyst says. Shares fall 0.3%. (adria.calatayud@wsj.com)
(END) Dow Jones Newswires
May 21, 2025 03:20 ET (07:20 GMT)
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