THURSDAY, April 4, 2019 -- U.S. Food and Drug Administration approval of Ibrance (palbociclib) capsules has been widened to include men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or spreading (metastatic) breast cancer, the agency said Thursday in a news release.
"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 Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.
Breast cancer among men is rare -- just 2,670 cases are estimated for all of 2019, which represents fewer than 1 percent of all predicted cases of the disease. Men are more likely to be diagnosed at an older age with a more advanced stage of the disease, the FDA said.
Ibrance was first approved in 2015. It is a kinase inhibitor, approved in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause.
Ibrance's most common side effects are infections, low levels of white blood cells, fatigue, nausea, inflammation of the mouth and lips, anemia, hair loss and diarrhea.
Doctors should tell male patients with female partners of child-bearing age to use contraception during treatment with Ibrance and for three months after the last dose, the agency advised.
Ibrance is produced by Pfizer, based in New York City.
Learn more about this approval.