FDA reapproves leukemia drug 7 years after pulled from market

Pfizer on Sept. 1 earned Food and Drug Administration approval for its acute myeloid leukemia drug Mylotarg.

Here are three things to know.

  1. Mylotarg may now be used to treat adults with newly diagnosed AML whose tumors express a specific antigen, along with patients two years and older who have experienced a relapse or have not responded to previous treatments.

  1. The FDA first granted Mylotarg accelerated approval in 2000. However, Pfizer voluntary withdrew the drug from the market in 2010 after confirmatory clinical trials demonstrated a higher number of early deaths among patients and failed to prove a clinical benefit.

  1. The newly approved version of Mylotarg features a lower recommended dose, a different treatment schedule and a new patient population.

"We are approving Mylotarg after a careful review of the new dosing regimen, which has shown that the benefits of this treatment outweigh the risk," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the agency's Office of Hematology and Oncology Products.

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