Pfizer Pulls Cancer Drug After Tests Show No Patient Benefit

Pfizer Inc. is pulling the leukemia drug Mylotarg from the market, after a new study showed no benefit for patients and a link to a liver disease that can be fatal, according to the Food and Drug Administration.

The agency asked the company to withdraw the drug after a clinical trial “raised new concerns about the product’s safety,” the FDA said in a statement.

Mylotarg was approved to treat acute myeloid leukemia in 2000 under the FDA’s accelerated approval program, which allows the agency to green light treatments for serious diseases based on early test results. It requires drug companies to complete further clinical trials after medications reach the market.

“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director of the FDA’s Office of Oncology Drug Products. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”

The drug was originally approved to treat patients over 60 with a recurrent form of the disease who could not have chemotherapy.

A 2004 trial that tested the benefit of taking the drug with chemotherapy ended when the medication showed no benefit and more patients taking it died than patients receiving chemotherapy alone.

Dr. Mace Rothenberg, a Pfizer senior vice president, said in a statement that the company is “disappointed that the study did not confirm the clinical benefit of Mylotarg,”

The product is no longer available to new patients, but patients already taking the drug may continue after consultation with their doctors, the agency said.

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