07-06-2010, 10:02 AM
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#158
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Come on, cat.
Join Date: Nov 2003
Location: general vicinity of Philadelphia area
Posts: 7,013
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Pfizer pulls leukemia drug from U.S. market
Quote:
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.
Mylotarg won approval under an abbreviated process to help bring treatments for serious diseases to patients more quickly. Medicines cleared in that way must pass follow-up tests to confirm they work.
The Food and Drug Administration said on Monday it asked Pfizer to withdraw the drug after 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."
Mylotarg's first-quarter sales were $8.8 million, making it a small product for the world's largest drugmaker. The company reported first quarter revenue of $16.8 billion. Pfizer acquired Mylotarg when it bought Wyeth in October 2009.
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.
The FDA cleared Mylotarg for sale in 2000
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