The U.S. Food and Drug Administration scolded Novartis for making false and misleading statements about a best-selling breast cancer treatment in a television ad in 2022.
In a letter dated Thursday, the agency admonished the company for touting the benefits of its Kisqali medicine by referencing data that did not support the messages in the ad. In particular, the FDA cited an analysis of patient-reported outcomes data that had limitations and failed to demonstrate Kisqali “helps preserve quality of life” or supports patients “living well.” The FDA also objected to formatting.
“This violation is particularly concerning because the overstated representations about Kisqali’s efficacy could lead patients with advanced or metastatic breast cancer… to believe that Kisqali has been shown to be more effective in treating their condition and symptoms — with respect to overall survival and quality of life — than was actually demonstrated,” the FDA wrote to Novartis about its television ad.