Pfizer uses real-world data to score Ibrance breast cancer nod in males
Breast cancer is a rare disease in men, making it tough for drugmakers to conduct clinical trials. But Pfizer came up with a solution. The pharma giant scored a new nod Thursday for big-seller Ibrance in males, based largely on real-world evidence. Along the way, regulators studied data from electronic health records and post-marketing reports from the IQVIA Insurance database, the Flatiron Health Breast Cancer database and Pfizer's own global safety database. The result? An FDA green light for Ibrance, in tandem with an aromatase inhibitor or AstraZeneca’s Faslodex, for men with HR-positive, HER2-negative advanced or metastatic breast cancer. Invasive breast cancer will affect 2,670 men in 2019, Pfizer estimates.