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.
“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,” Chris Boshoff, M.D., Ph.D., Pfizer’s chief oncology development officer, said in a statement.
Drugmakers have been turning for years now to real-world data to help justify their pricing decisions to payers, but recently they’ve looked to use a product’s performance in the real world to help make their case for new indications with regulators. In 2016, the 21st Century Cures Act laid the groundwork for greater use of real-world data in drug approvals, and the new Ibrance nod is a testament to recent progress in that area.
The move also gives Ibrance a new sales avenue—albeit a limited one—in a crowded field. Pfizer is counting on the drug to keep up growth as it faces the decline of fellow blockbuster Lyrica, which will face generic competition in June. But Novartis’ Kisqali and Eli Lilly’s Verzenio are chasing after Ibrance after receiving 2017 FDA approvals of their own.