FDA Approves Novartis' Piqray for Breast Cancer
May 24 2019 - 3:47PM
Dow Jones News
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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