(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday approved Pfizer Inc’s drug, Mylotarg, for certain patients with acute myeloid leukemia (AML), re-clearing a drug that had been pulled off the market in 2010.
The drug was cleared to treat adults with newly diagnosed AML and tumors expressing the CD33 antigen, as well as patients aged 2 years and older with CD33-positive AML who have relapsed, or did not 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.
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as a standalone treatment for adult patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn as subsequent confirmatory studies failed to show clinical benefit and had safety concerns, including a high number of deaths.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.
A cycle of Mylotarg is expected to cost $24,600, Pfizer 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.
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 those, 10,590 patients will succumb to the disease, according to estimates from the National Cancer Institute.