Aventis' chess-themed direct-to-consumer ads for the breast and lung cancer therapy Taxotere "misleadingly...imply that survival depends on treatment with Taxotere," FDA told the company in a warning letter.

The letter, sent in November but not released by FDA until Dec. 11, cites Aventis print ads first published in 2002 and re-run in 2003 that use the image of a chess board and the headline "The Next Move May Be The Key To Survival." The ads also feature the Taxotere logo and the tag line, "It's your move."

The headline "suggests to cancer patients that if they want to survive breast or lung cancer, the next course of cancer treatment (or 'next move') should include Taxotere," the ¹ warning letter states.

While the ads imply a "significant" survival impact, FDA said, "the survival differences observed in clinical trials with Taxotere were at best several months, were observed in specific populations as described in the indications above, and did not necessarily represent long-term survival or a cure."

"Your claim also implies to patients that if they do not add Taxotere to their treatment, they will not survive," FDA said. "This is misleading, given that there are other treatments available for breast cancer and lung cancer with proven survival benefits."

Taxotere is indicated for second-line treatment of locally advanced or metastatic breast cancer; second-line treatment of NSCLC; and first-line use in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic NSCLC (² 'The Pink Sheet' Dec. 9, 2002, In Brief).

The agency indicated particular concern that there are combination regimens that have been shown to be superior to Taxotere in first-line treatment of advanced non-small cell lung cancer.

FDA noted that Aventis sought an indication for "treatment of patients with chemotherapy-naïve locally advanced or metastatic NSCLC," but withdrew the NDA because "the data...did not establish the safety or effectiveness of Taxotere for first-line treatment."

The warning letter also cites a year-long interaction between FDA and the company over Taxotere promotions following an ³ 'untitled' letter sent to the company Dec. 18, 2002 objecting to chess-themed physician promotions that the agency believed overstated Taxotere's survival benefit.

Aventis responded to the letter by assuring FDA that it had discontinued the materials in question and destroyed any similar materials. In January, FDA followed up by asking Aventis to provide an inventory of the materials that were discontinued. Aventis submitted a list of 12 items.

FDA "again contacted Aventis by telephone" on Jan. 27 to ask the company to check again. The agency "was particularly concerned that Aventis issued a 'Dear Doctor' letter dated December 2002 with similar violations," the warning letter states. The agency also pointed out to Aventis that the "Dear Doctor" letter was not submitted to the ad division.

Aventis responded that the letter "was intended for one-time use and has been destroyed," FDA said. The company also reported one other discontinued item.

FDA informed the company in July that it had identified two DTC ads that ran in People magazine as raising "concerns similar to those that were highlighted in the Dec. 18, 2002 untitled letter."

Aventis disagreed, telling FDA that "we did not believe the untitled letter applied to these pieces...and we continue to believe that the information presented in these ads is not inappropriate for the intended use as consumer communications."

The company also told the agency that it was still running similar ads in other magazines. However, in light of the agency's concerns, Aventis said it pulled scheduled runs for the fall.

FDA asks Aventis to provide "a plan of action to disseminate accurate and complete information to the audience(s) that received the violative promotional materials."

The agency also told Aventis that it is "continuing to evaluate other aspects of your promotional campaign for Taxotere and may determine that additional measures will be necessary to fully correct the false and misleading messages from your violative conduct."

Game Over: FDA Warns Aventis For Repeat Use Of Taxotere Chess-Theme Ads

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