Regulatory Focus™ > News Articles > FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims

FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims

Posted 15 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Genentech over marketing materials used to promote its drug Tarceva (erlotinib), used to treat metastatic non-small cell lung cancer (NSCLC).

OPDP's letter references a visual aid entitled, "Improving Outcomes in First-Line Advanced Pancreatic Cancer." The advertisement depicts an adult and child in a mostly-horizontal hourglass on a beach, lounging comfortably and reading a book together. "Tarceva is proven to extend overall survival," the ad goes on to state, referencing a series of studies that the company said shows a "significantly prolonged progression-free survival (PFS) in a broad patient population."

But FDA claims the company's ad discounts risk information and makes Tarceva out to be more effective than it actually is. FDA said one presentation of data in particular seemed to imply Tarceva alone was responsible for a 3.7-month extension in overall survival, when studies actually showed Tarceva was only responsible for approximately 12 days of that extension. FDA alleged that the claim was therefore misleading.

Regulators also took issue with how Genentech used a retrospective analysis to obtain its data, noting that the analyzed data were, "not pre-specified endpoints in the pivotal study."

"The data and subsequent claims presented in this sales aid were derived from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited above," concluded FDA. A second set of claims made by Genentech in the advertisement was also highlighted as suspect by FDA for the same reason-"the exploratory, retrospective analysis of efficacy in these patient subgroups is not supported due to the lack of adequate prospective statistical design."

But not all of FDA's allegations had to do with subgroup analyses. It pointed to the combination of the sideways hourglass and corresponding text-"Extending survival for moments that matter." FDA said the sideways position of the hourglass makes it," appear that the sand in the upper half is no longer flowing down to the lower half where the cancer patient and child are located."

"This presentation strongly suggests that time is standing still for the cancer patient because of Tarceva therapy," continued FDA. "This suggestion drastically overstates the overall survival benefit for patients." FDA added that the data used to approve the drug did not show its capability to, "Greatly improve survival to the extent implied by the hourglass presentation."

Finally, FDA alleges the ad fails to mention some important risk information by focusing instead on "common adverse reaction," while failing to list uncommon but potentially fatal adverse reactions that have also occurred. "By failing to mention any of the serious, potentially fatal risks associated with Tarceva, this presentation misleadingly suggests that Tarceva is safer than has been demonstrated by substantial evidence," claimed FDA.

FDA's letter requests that Genentech cease dissemination of the promotional material immediately and submit a written response to FDA by 18 October.

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