Pfizer’s Ibrance granted expanded approval to include male patients

The FDA is extending 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 granted the approval of Ibrance to Pfizer. “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.

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