Potentially lethal leukemia drug re-approved by the US

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The US Food and Drug Administration (FDA) on Friday re-approved Pfizer’s drug, Mylotarg, for certain patients with acute myeloid leukemia (AML). Drug was earlier voluntarily withdrawn. The new approval has low dosage and a different dosing schedule for the drug.

The drug was cleared to treat adults with newly diagnosed AML whose tumors express the CD33 antigen, as well as patients aged two years and older with CD33-positive AML who have relapsed, or did respond to initial treatment.

The FDA said the drug has a boxed warning as it may cause severe or fatal liver damage, including blockage of veins in the liver.

Pfizer attains FDA breakthrough approval for leukemia drug. /American Pharmacy News Photo

Mylotarg got accelerated approval in 2000 as a standalone treatment for adult patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn as subsequent confirmatory studies failed to show clinical benefit and had safety concerns, including a high number of deaths.

Friday’s approval includes a lower recommended dose, a different dosing schedule and a new patient population, the FDA said.

Mylotarg is thought to work by taking the anti-tumor agent to the AML cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death.

Pfizer company logo is seen in Dublin. /Reuters Photo

AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells.

About 21,380 people will be diagnosed with AML this year and of that 10,590 patients will succumb to the disease, according to estimates from the US National Cancer Institute.

Source(s): Reuters