Pfizer says FDA approves sNDA to expand indications for IBRANCE
Pfizer announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application to expand the indications for IBRANCE in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The approval is based on data from electronic health records and postmarketing reports of the real-world use of IBRANCE in male patients sourced from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database. "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, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "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."