Breast Cancer Drug Gains Approval for Males


Ibrance product image

Image Credit: Cancer Health

The FDA has extended the indication for breast cancer drug Ibrance (palbociclib) to male patients. 

Originally approved in 2015, Ibrance is indicated for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with either an aromatase inhibitor as initial endocrine-based therapy or fulvestrant in patients with disease progression following endocrine therapy.

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The FDA says breast cancer in males is relatively rare, with an estimated 2,670 cases to be reported in 2019. When compared with the total cases of breast cancer, the estimated male cases would make up 1% of all cancer cases. 

Side effects of Ibrance include infections, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea, thrombocytopenia. Other common side effects include rash, vomiting, decreased appetite, asthenia, and fever. 

The FDA also suggests that males with female partners of reproductive potential ensure effective use of contraception during and up to three months after the final dose of ibrance, as the medication is known to cause genotoxic effects. 



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