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Today, pharmaceutical company Pfizer, the world's largest drug maker, announced it is voluntarily pulling the drug Mylotarg off the market after ten years. The drug is used to treat a rare form of bone marrow cancer. It was initially approved in 2000 by the FDA, in an abbreviated approval process meant to get treatments for serious illnesses to market more quickly. Any drug approved under this process was required to undergo follow-up testing after it appeared on the market.
According to a report by Reuters, a recent follow up study on Mylotarg showed the drug, when added to chemotherapy, was not effective in extending the survival rate of patients with previously untreated acute myeloid leukemia. The FDA said in its statement that the study "raised new concerns about the product's safety," and that the drug "failed to demonstrate clinical benefit to patients enrolled in trials."
Reuters further reports that according to Pfizer, 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.
According to a report by Bloomberg, the FDA says Wyeth (the drug's original producer) began a required study designed to confirm Mylotarg’s benefits in 2004, four years after it won the conditional marketing clearance. The agency notes that this points up the need for more oversight on the follow-up studies necessary for the drugs pushed through on the accelerated approval process.
“We are disappointed that the study did not confirm the clinical benefit of Mylotarg,” said Mace Rothenberg, senior vice president of clinical development for Pfizer's cancer business unit, in a statement released today.
Reuters writes pharmaceutical company Pfizer acquired the drug when it bought Wyeth in October 2009. Mylotarg's first-quarter sales were $8.8 million.
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