Novartis Overstates Kisqali Effectiveness in TV Ad, FDA Says in Untitled Letter

The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the company an untitled letter.

Kisqali treats adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with other drugs.

The FDA’s letter says the ad “claims that Kisqali ‘preserves quality of life’ and that patients taking the drug are ‘living well’ create a misleading impression that Kisqali has demonstrated a benefit on the patient reported outcome (PRO) measure of global quality of life (QoL). In fact, we note significant limitations to the PRO analysis described in the cited reference.”

Read the untitled letter here.

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