Roche Needs More US Data on Key Cancer Drug, FDA Advisers Say
A group of advisers to the Food and Drug Administration said Roche Holding AG needs to study its blood cancer treatment in more American patients before its use can be expanded.
Independent experts voted eight-to-one that the results of a pivotal Roche trial, which enrolled just 9% of its total patients from the US, weren't applicable to the domestic population. They asked the Swiss company to gather more data. Roche said in a statement it would continue working with the FDA on a regulatory path forward.
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