April 04, 2019
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FDA approves Ibrance for certain men with metastatic breast cancer

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Richard Pazdur, MD
Richard Pazdur

The FDA has expanded the indications for palbociclib to include men with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

The new indication applies to the use of palbociclib (Ibrance, Pfizer) — a cyclin-dependent kinase 4/6 inhibitor — in combination with specific endocrine therapies.

The FDA previously approved palbociclib for the same type of cancer in postmenopausal women when used in combination with an aromatase inhibitor as initial hormone-based therapy or in combination with fulvestrant. Pfizer provided postmarketing approval data to the FDA to support expanding the indications to include 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,” 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, said in a press release. “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.”

Adverse events most commonly reported with palbociclib include leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea and thrombocytopenia.

The FDA recommended that health care professionals advise male patients to use effective contraceptive methods because of potential reproductive side effects related to cell damage that can last up to 3 months after the last dose of palbociclib.