Genentech amends trial protocol as FDA gets tough on accelerated cancer drug approvals
This article was originally published in Scrip
With the US FDA issuing a rare refusal to file letter for Genentech's (Roche) trastuzumab-DM1 (T-DM1) to treat HER2-positive breast cancer on the basis of a single-arm Phase II trial that it submitted for accelerated approval, the company is now amending its ongoing Phase III trial of the drug so that it can show improved overall survival.
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