Novartis has agreed to remove claims of survival benefit from its consumer advertising for its breast cancer drug Kisqali (ribociclib), as recommended by the National Advertising Division (NAD) of BBB National Programs.
NAD determined that similar claims can remain in Kisqali advertising directed to healthcare professionals.
The action follows a challenge by Eli Lilly, manufacturer of the competing metastatic breast cancer drug Verzenio (abemaciclin), regarding claims of survival benefit in Novartis’ Kisqali advertising campaign.
At issue was whether survival claims made by Novartis convey a message of superiority over other drugs in the class.
NAD, having deemed healthcare providers and specialists “a sophisticated audience…better equipped to decipher the advertised results of clinical data than the general consumer,” stated that Novartis “provided a reasonable basis for the claim that its Kisqali breast cancer treatment drug is ‘[t]he only CDK4/6 inhibitor with statistically significant overall survival proven across 3 phase III trials’ when directed to an audience of health care professionals.”
However, NAD concluded that “one message reasonably conveyed to consumers, who…lack the medical knowledge or experience to understand nuances in clinical trial design or outcomes, is that Kisqali is more effective and provides superior survival benefits.”
NAD also determined that the studies submitted by Novartis to back its claims were “not similar enough to compare the overall survival data or other results.”
The NAD decision notes that Novartis, on the basis of an advertiser statement, “respectfully disagrees with NAD’s findings” but plans to comply with the recommendation to remove the relevant claims from consumer advertising.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on Twitter: @SW_MedReporter.
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