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Concerns focus on recent data showing lack of clinical benefit, increased number of deaths

-- Eric Metcalf

Tuesday, June 22, 2010 (Last Updated: 06/23/2010)

TUESDAY, June 22 (HealthDay News) -- Gemtuzumab ozogamicin (Mylotarg) -- used in treating acute myeloid leukemia (AML) -- has been voluntarily withdrawn from the U.S. market following concerns over a recent clinical trial, according to a June 21 news release from the U.S. Food and Drug Administration.

The drug was approved in May 2000 -- as part of the FDA's accelerated approval program -- for patients ages 60 and older with recurrent AML who weren't candidates for other chemotherapy. According to the FDA, in 2004, Wyeth -- now Pfizer -- began a confirmatory clinical trial to assess whether adding Mylotarg to standard chemotherapy was associated with improved survival time.

The trial was halted early after a failure to demonstrate an improvement in clinical benefit, as well as a higher number of deaths in patients receiving Mylotarg compared to chemotherapy alone. The drug will not be commercially available to new patients, according to the FDA, but patients currently receiving it may complete their therapy after consulting with their health care provider.

"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," Richard Pazdur, M.D., director of the FDA's Office of Oncology Drug Products, said in a statement. "However, a confirmatory clinical trial and years of post-marketing experience with the product have not shown evidence of clinical benefit in patients with AML."

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Specialties Dermatology
Hematology & Oncology
Family Practice
Internal Medicine
Pathology

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