FDA Expands Approval of Novartis Breast Cancer Drug
July 18 2018 - 12:57PM
Dow Jones News
By Nishant Mohan
The U.S. Food and Drug Administration said Wednesday it expanded
its approval of a Novartis AG breast cancer drug to include
treatment of certain premenopausal women.
The FDA approved the ribociclib drug Kisqali last year for use
only in certain post-menopausal women.
The Swiss pharmaceutical company said it has more than 2,000
patients enrolled in ongoing trials of drug to be used in
combination with an aromatase inhibitor as an initial
endocrine-based therapy.
The approval is the first to come out of two new FDA pilot
programs to cut the time it takes to review cancer drugs by
allowing the FDA early access to data of completed trials and
streamlining data submission with a template.
Shares of Novartis AG gained 3.15% to $80.66. ADRs of the
company rose 2.35% to $80.55.
Write to Nishant Mohan at nishant.mohan@wsj.com
(END) Dow Jones Newswires
July 18, 2018 12:42 ET (16:42 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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