Drugmaker Pfizer Inc is pulling a decade-old leukemia medicine off the U.S. market after a study found a higher death rate and no benefit for patients, Reuters quoted U.S. health officials as saying today. The drug, Mylotarg, won approval in 2000 under an abbreviated process for treatments for serious diseases. Medicines cleared in that manner must pass follow-up tests to confirm they work. A recent clinical trial "raised new concerns about the product's safety," and the drug "failed to demonstrate clinical benefit to patients enrolled in trials," the Food and Drug Administration said in a statement. Pfizer acquired the drug when it bought Wyeth in October 2009. Mylotarg's first-quarter sales were $8.8 million. The world's largest drugmaker said it was voluntarily withdrawing the medicine after a study showed adding Mylotarg to chemotherapy did not extend survival for patients with previously untreated acute myeloid leukemia. "We are disappointed that the study did not confirm the clinical benefit of Mylotarg," Dr. Mace Rothenberg, a Pfizer senior vice president, said in a statement. The trial also showed more deaths in the first couple months of treatment. The fatality rate was 5.7 percent for Mylotarg patients, compared with 1.4 percent without the drug, Pfizer said. Pfizer shares fell nearly 1 percent to $15.06 in afternoon trading on the New York Stock Exchange.
