FDA Policy/General

OPDP Letter Cites Novartis on Kisqali Ad

CDER’s Office of Prescription Drug Promotion (OPDP) has faulted a Novartis direct-to-consumer TV ad promoting it breast cancer therapy Kisqali (ribociclib) for false or misleading efficacy representations. “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,” a just-release untitled letter says.

Specifically, OPDP objects to Novartis’ claims that Kisqali “preserves quality of life” and that patients taking the drug are “living well,” which create misleading impressions that Kisqali has “demonstrated a benefit on the patient reported outcome (PRO) measure of global quality of life (QoL),” according to the letter. “In fact, we note significant limitations to the PRO analysis described in the cited reference (the MONALEESA-2 clinical trial) which preclude the drawing of such conclusions regarding benefits related to QoL.”

Additionally, the letter takes issue with the ad’s superimposed text that includes material information for “long live” and “live longer” claims. It says the text presents 48 words in about five seconds, which translates to a reading speed of 576 words per minut. “The number of words in the super is more than twice the number of words, on average, than an adult can read within five seconds,” the letter says.

OPDP’s letter asks Novartis to stop this and any other violations of the agency’s regulations. “Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for Kisqali that contain representations like those described above, and explaining any plan for discontinuing use of such communications, or for ceasing distribution of Kisqali,” the letter says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome