Roche Submits Breast-Cancer Drug Application to FDA
February 05 2019 - 1:56AM
Dow Jones News
By Olivia Bugault
Roche Holding AG (ROg.EB) said Tuesday that it submitted a
supplemental biologics license application to the U.S. Food and
Drug Administration for its breast-cancer medicine Kadcyla.
Kadcyla was granted breakthrough therapy designation, which is
assigned to drugs designed to treat serious or life-threatening
diseases, the Swiss pharmaceutical giant said.
Sandra Horning, Roche's chief medical officer and head of global
product development, said Roche is working "closely with the FDA to
bring Kadcyla to people with HER2-positive early breast cancer who
have residual disease after neoadjuvant therapy as early as
possible."
Write to Olivia Bugault at olivia.bugault@dowjones.com
(END) Dow Jones Newswires
February 05, 2019 01:41 ET (06:41 GMT)
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