Roche Needs More US Data on Key Cancer Drug, FDA Advisers Say

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.

Updated: FDA adcomm splits votes on Genentech and J&J cancer drugs

The FDA's Oncologic Drugs Advisory Committee voted 8 to 1 against whether Genentech's pivotal trial is applicable to the US patient population for a Columvi label expansion. In the afternoon session, the same committee voted ...