Novartis’ marketing team has received a dressing-down from the FDA. After reviewing an ad for breast cancer drug Kisqali, the agency accused (PDF) Novartis of making false or misleading representations about the treatment’s efficacy.
The untitled letter covers a “Long Live” TV ad that Novartis submitted for review by the FDA’s Office of Prescription Drug Promotion. An ad with that title and content that matches the concerns raised by the FDA ran in Dec. 2022. In the ad, Novartis states, through the voiceover and on-screen text, that Kisqali enables patients to live longer and helps preserve their quality of life.
Officials found fault with aspects of how Novartis presented both claims. A dissection of the evidence to support the claim that Kisqali helps patients’ preserve their quality of life forms the centerpiece of the untitled letter.
Novartis used patient-reported outcomes (PROs) to assess quality of life but the statistical design of the study means the FDA considers the data exploratory. “They do not, as you have claimed, demonstrate that Kisqali ‘helps preserve quality of life’ or that it supports patients ‘living well’,” the FDA wrote.
That is just one of the limitations of the PRO data identified by the FDA in the letter. The FDA also picked apart the frequency of assessments and the failure to account for confounding factors, before turning its attention to the idea that preserving quality of life means patients are “living well.” Patients may not be “living well” at baseline, given their disease, and the FDA took issue with Novartis’ use of the phrase.
The SUPER, small text at the bottom of the screen, states the median time to worsening of at least 10% in quality of life scores at a 26-month check-in—27.7 months in the Kisqali cohort and 27.6 months in the control arm—and explains that the “analysis was not pre-planned to detect a false positive.” However, the FDA said the inclusion of that caveat “is not sufficient to mitigate the overall misleading impression.”
Novartis’ claims that patients taking Kisqali “live longer” is on firmer ground, with the drugmaker linking a regimen featuring the drug to median overall survival of 63.9 months compared to 51.4 months for the control. But the FDA is unhappy with how the company qualified its claims, noting that the data, shared in a SUPER, was “undermined by multiple, competing presentational aspects that distract the viewer.”
The agency also challenged Novartis about how long it displayed the survival data. With the 48-word text on screen for five seconds, the viewer would need to read at 576 words per minute (wpm) to take it all in. The FDA cited a meta-analysis that found most adults read at 175 to 300 wpm to bolster its case that the “ad misleadingly undermines the communication of material information about the drug’s efficacy.”