Press Announcements > FDA expands approved use of metastatic breast cancer treatment to include male patients

Press Announcements > FDA expands approved use of metastatic breast cancer treatment to include male patients

FDA expands approved use of metastatic breast cancer treatment to include male patients 

The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.  “Today we are expanding the indication for Ibrance to include male patients based upon 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 treated with Ibrance,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Some approved indications for breast cancer treatments do not distinguish by gender, but in certain cases if there is..."

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