Genentech Says FDA Approves Kadcyla for Treatment of Some Breast Cancer Patients
May 03 2019 - 4:37PM
Dow Jones News
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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