By Stephen Nakrosis 
 

Genentech said on Friday the U.S. Food and Drug Administration approved Kadcyla, or ado-trastuzumab emtansine, for after-surgery treatment of some people with HER2-positive early breast cancer.

Genentech said the FDA based its approval "on data showing Kadcyla cut the risk of disease recurring by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer."

Genentech said its application was reviewed and approved under the FDA's Real-Time Oncology Review and Assessment Aid pilot programs, leading to an approval 12 weeks after completing the submission.

Genentech is a member of the Roche Group.

 

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

May 03, 2019 16:22 ET (20:22 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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