Pfizer voluntarily withdraws Mylotarg

SILVER SPRING, Md. Pfizer has withdrawn one of its cancer drugs from the market at the request of the Food and Drug Administration amid concerns about its safety and efficacy, the FDA said Monday.

The drug maker started the voluntary withdrawal of the drug Mylotarg (gemtuzumab ozogamicin), used to treat acute myeloid leukemia, following the abrupt halting of a post-marketing trial in which patients taking Mylotarg with chemotherapy showed no clinical benefit and also died at a higher rate than those taking chemotherapy alone. Wyeth, now part of Pfizer and the original developer of the drug, started the trial in 2004. The drug was approved under the FDA’s accelerated approval program in 2000 for patients aged 60 and older with AML.

“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,” FDA Center for Drug Evaluation and Research Office of Oncology Drug Products director Richard Pazdur 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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