FDA approves palbociclib for men with HR+/HER2- advanced breast cancer


The Food and Drug Administration has expanded the indication of palbociclib (Ibrance) 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 men.

FDA icon

Approval was based on postmarketing reports and electronic health records showing that the safety profile for men is consistent with that of women, the FDA said in a statement.

Less than 1% of all cases of breast cancer occur in men, but in the majority of those cases the tumors do express hormone receptors. Men are more likely to be diagnosed at a more advanced stage of disease. “According to the current clinical practice standards, male patients with breast cancer are treated similarly to women with breast cancer,” the FDA said.

The kinase inhibitor palbociclib was initially approved in 2015, in combination with an aromatase inhibitor, for postmenopausal women as first-line treatment of advanced disease.

The most common side effects in patients taking palbociclib are infections, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea, and thrombocytopenia.

Because of the potential for genotoxicity, the FDA advised health care providers to tell male patients with female partners of reproductive potential to use effective contraception during treatment with palbociclib and for 3 months after the last dose.

Next Article: