WASHINGTON — Pfizer Inc. exaggerated benefits and downplayed risks of its breast cancer drug, Xalkori, to boost sales and win approval for its use among some of the highest-risk patients, the Food and Drug Administration said Monday in a letter to the company.
The agency said it would not approve the drug for use in adults with triple-negative breast cancer, based on clinical trials it conducted in people with that tumor type, noting that one of the trials showed patients appeared to live significantly longer with the drug than they did without it.
That finding is something that would have been “hard to miss” in documents Pfizer made public with its application to the FDA, the agency said.
FDA “concluded that, had Pfizer disclosed these patients’ higher survival rates earlier, the company’s application may have met the requirements for FDA approval of an expanded indication,” it said.
Miles D. White, Pfizer’s chairman and chief executive, insisted that his company had been transparent.
“It is clear from our discussions with the FDA that its review was not based on perceptions of the information, but on a careful review of the clinical trial data and the totality of the scientific information,” he said in a statement.
Pfizer said it was disappointed with the FDA’s decision and will respond to the agency’s letter.