FDA Expands Approved Use of Pfizer's Ibrance to Men With Breast Cancer

Date : 04/04/2019 @ 21h37
Source : Dow Jones News
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FDA Expands Approved Use of Pfizer's Ibrance to Men With Breast Cancer

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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)

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