FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA OK’s Ibrance for Breast Cancer in Men

April 15, 2019
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The FDA approved Pfizer’s Ibrance (palbociclib) for breast cancer in men, expanding the drug’s indications in combination with an aromatase inhibitor or fulvestrant.

The drug is now approved for treating men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

"With this approval, we are now able to offer Ibrance to the underserved male breast cancer community and provide more patients with HR+, HER2- metastatic breast cancer the opportunity to access an innovative medicine," said Chris Boshoff, Pfizer’s chief development officer of oncology.

The agency’s go-ahead makes the medicine the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of males with HR+, HER2- metastatic breast cancer in the US.

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