Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its request to expand the indications for Ibrance (palbociclib) to include the treatment of men with breast cancer.
The drug’s label will now include use in combination with an aromatase inhibitor or fulvestrant to treat men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
This makes Ibrance the only cyclin-dependent kinase (CDK) 4/6 inhibitor in combination with an aromatase inhibitor indicated for men with HR+, HER2- metastatic breast cancer in the US.
This approval is based on real world data from electronic health records and postmarketing records of the use of Ibrance in male patients. Since breast cancer is rare in males, it is harder to conduct clinical trials for this disease, meaning fewer treatment options.
Male Breast Cancer Coalition founder Bret Miller said: “Men with breast cancer have limited treatment options, making access to medicines such as IBRANCE critically important.
“We applaud the use of real-world data, a new approach to drug review, to make IBRANCE available to certain men with metastatic breast cancer and help address an unmet need for these patients.”
Pfizer global oncology product development chief development officer Chris Boshoff said: “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.
Ibrance was first approved in the US in combination with aromatase inhibitor letrozole for postmenopausal women with estrogen receptor-positive, HER2- breast cancer in February 2015.
The FDA then expanded the drug’s indication in 2016 to include women with HR+ and HER2- advanced or metastatic breast cancer in combination with fulvestrant following disease progression with endocrine therapy.
Its label was expanded again in March 2017 when the Ibrance was approved in combination with any aromatase inhibitor, not only letrozole; therefore broadening the anti-hormonal therapy that can be administered with Ibrance.