OPDP says Novartis’ Kisqali TV ad makes false or misleading representations

The Office of Prescription Drug Promotion of the U.S. Food and Drug Administration said in a letter that it has reviewed the promotional communication, a direct-to-consumer broadcast advertisement, “KISQALI_MBC_Long Live-Post Meno_US_11.22” for KISQALI tablets, for oral use submitted by Novartis Pharmaceuticals Corporation under cover of Form FDA 2253. The TV ad makes false or misleading representations about the efficacy of Kisqali. Thus, the TV ad misbrands Kisqali within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352 (n); 321(n); 331(a). 21 CFR 202.1(e)(5). This violation is particularly concerning because the overstated representations about Kisqali’s efficacy could lead patients with advanced or metastatic breast cancer, an incurable condition whose treatment involves serious risks, to believe that Kisqali has been shown to be more effective in treating their condition and symptoms (e.g., with respect to overall survival and quality of life) than was actually demonstrated. Breast cancer is a serious public health concern in the United States with 297,790 new cases and 43,170 deaths estimated in 2023 in female patients.