The US Food and Drug Administration (FDA) has approved Pfizer Inc’s drug, Mylotarg, for certain patients with acute myeloid leukaemia (AML), re-clearing a drug that was pulled off the market in 2010.
Reuters Health reports that the drug was cleared to treat adults with newly diagnosed AML and tumours 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as a standalone treatment for adult patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn as subsequent confirmatory studies failed to show clinical benefit and had safety concerns, including a high number of deaths.
The 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-tumour 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.Reuters Health report