FDA staff questions Clovis drug’s efficacy over current treatments
(Reuters) – Staff reviewers from the U.S. Food and Drug Administration on Friday questioned if Clovis Oncology Inc’s lung cancer drug was more effective than available treatments. The reviewers also recommended including a black box warning, the FDA’s strictest warning, in the drug’s label. (http://1.usa.gov/1WhpSFa) Rociletinib, which is very similar to an AstraZeneca Plc drug already on the market, targets patients whose disease has worsened after treatment with other therapies. (Reporting by Amrutha Penumudi and Natalie Grover in Bengaluru; Editing by Sriraj Kalluvila)