The FDA has chosen to expand the indications of Pfizer’s Ibrance (palbociclib), the company announced, approving the CDK4/6 inhibitor in combination with an aromatase inhibitor or fulvestrant in the treatment of men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

The decision was based primarily on real-world data derived from a range of electronic health records and postmarketing reports from a range of sources, including the IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database. These sources were especially significant given the rarity of male breast cancer.

"Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important," said Bret Miller, founder of the Male Breast Cancer Coalition. "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."

Dr Chris Boshoff, Chief Development Officer, Oncology, Pfizer Global Product Development, added: "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. We appreciate that our partnership with the FDA has allowed us to take a significant step forward in the use of real-world data to bring medicines to patients who are most in need."

Pfizer confirmed that full details of the data used to support the approval will be presented at an upcoming medical meeting.

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