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Name | Symbol | Market | Type |
---|---|---|---|
Novartis AG | NYSE:NVS | NYSE | Depository Receipt |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
-0.12 | -0.13% | 93.08 | 93.78 | 92.87 | 93.63 | 1,168,714 | 21:15:52 |
By Michael Dabaie
The U.S. Food and Drug Administration said it granted Novartis AG (NVS) approval of its Piqray treatment for breast cancer.
FDA said it approved the drug to be used in combination with fulvestrant to treat postmenopausal women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
The FDA also granted approval for the companion diagnostic test to QIAGEN Manchester Ltd.
"Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer," said Richard Pazdur acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
May 24, 2019 15:32 ET (19:32 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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