The Food and Drug Administration (FDA) has expanded the indication of Ibrance (palbociclib; Pfizer) for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients, in combination with an aromatase inhibitor or fulvestrant.

The FDA’s expanded approval was supported by “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, MD, 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.

Results from a real-world analysis from electronic health records were included as supportive data to establish the use of palbociclib plus endocrine therapy in male patients with breast cancer according to observed tumor responses. Additional data on the effects of palbociclib in men with HR-positive, HER2- advanced or metastatic breast cancer will be presented at an upcoming medical meeting.

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Infections, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea, and thrombocytopenia are the most common adverse effects associated with Ibrance. Due to potential genotoxicity, male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.

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Palbociclib, a kinase inhibitor, is already approved for HR-positve, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or fulvestrant in women with disease progression following endocrine therapy.

Ibrance is supplied as 75mg, 100mg, and 125mg capsules.

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This article originally appeared on MPR