Promotional materials for a handful of biologics have found their way into the FDA’s hot seat.
The regulator’s avowed crackdown on direct-to-consumer pharmaceutical advertising that began in earnest last fall has resulted in dozens of untitled letters flagging perceived issues in marketing materials. The vast majority of those missives, however, have centered on conventional small-molecule drugs; when the frenzy began in September, only one untitled letter went to a product under the purview of the FDA’s Center for Biologics Evaluation and Research (CBER), and before that, CBER’s last untitled letter dated back to 2018.
The group of four untitled letters uploaded to the CBER database this month, then, is a rarity. All are dated March 9, and each takes issue with promo materials for a different biologic medicine—from the likes of Iovance Biotherapeutics, Bristol Myers Squibb, Novartis and Gilead Sciences’ Kite Pharma—that the agency has deemed “false or misleading.”
All four of the letters single out mentions of or references to “exploratory analyses” beyond the outcome measures in single-arm studies that earned each biologic’s FDA approval. Each missive includes a nearly identical statement that its listed violations “are particularly concerning from a public health perspective because the promotional materials make misleading representations about [the biologic] being more effective or having greater clinical benefit than has been demonstrated. This may cause doctors and patients to inaccurately weigh the risks versus benefits of treatment with [the biologic], which can be fatal or life-threatening.”
The letters acknowledge footnotes and fine print from the companies noting that the datapoints in question should be interpreted with caution, but countered that they “do not sufficiently mitigate the overall misleading message conveyed by these materials.”
Iovance’s letter (PDF) flags a laundry list of materials regarding its skin cancer med Amtagvi, including slide decks, conference booth panels, branded emails, a clinician-facing website and more.
All of the identified items reportedly include references to overall survival (OS) data from studies of Amtagvi. That’s potentially misleading, according to the FDA, because the biologic was approved based on objective response rate, with additional studies still ongoing.
BMS, meanwhile, received a letter (PDF) about its B-cell lymphoma treatment Breyanzi. Per the FDA, the healthcare provider-facing website and promotional labeling include representations of OS and progression-free survival (PFS) benefits for Breyanzi, despite the med being approved based only on response rate and duration of response.
Novartis’ letter (PDF) homes in on half a dozen sales and marketing materials for its own blood cancer med Kymriah, which the FDA said also incorrectly reference OS and PFS data, since the biologic was approved in multiple indications based on various combinations of ORR, duration of response, complete remission (CR) and minimal residual disease.
Finally, the letter (PDF) sent to Gilead’s Kite subsidiary points to an HCP website and sales aid for yet another blood cancer med, Tecartus. Those materials reportedly refer to PFS, OS and relapse-free survival benefits, while Tecartus was greenlit based on ORR and duration of response in one indication and CR and duration of CR in another.
In each case, the companies were given 15 working days to respond to the FDA’s listed concerns. As of publication time Monday, only Gilead had replied to Fierce Pharma Marketing’s request for comment.
In a statement sent to Fierce, a Gilead spokesperson confirmed receipt of the letter, adding, “The materials were previously reviewed by the FDA, and Kite followed established regulatory procedures. We take patient safety and compliance seriously and are working to ensure our communications are accurate, balanced, and consistent with the Tecartus prescribing information. We are reviewing the FDA’s feedback and working cooperatively with the Agency to address its comments.”