FDA Expands Approved Use of Pfizer's Ibrance to Men With Breast Cancer
04 Avril 2019 - 9:37PM
Dow Jones News
By Michael Dabaie
The U.S. Food and Drug Administration said Thursday it expanded
the approved use of Pfizer Inc.'s (PFE) Ibrance breast cancer
treatment to include male patients.
The FDA said it expanded the indication of Ibrance capsules in
combination with specific endocrine therapies for hormone
receptor-positive, human epidermal growth factor receptor
2-negative advanced or metastatic breast cancer in male
patients.
The FDA said it made the move based on data from postmarketing
reports and electronic health records showing that the safety
profile for men treated with Ibrance is consistent with the safety
profile in women.
"Some approved indications for breast cancer treatments do not
distinguish by gender, but in certain cases if there is a concern
that there may be a difference in efficacy or safety results
between men and women, then further data may be necessary to
support a labeling indication for male patients," said Richard
Pazdur, director of the FDA's Oncology Center of Excellence and
acting director of the Office of Hematology and Oncology
Products.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
April 04, 2019 15:22 ET (19:22 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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