Cancer Drug Removed From U.S. Market
From UPI Science News (June 21, 2010)
Pfizer Inc. announced Monday it is withdrawing its cancer drug Mylotarg for use by U.S. patients with acute myeloid leukemia -- a bone marrow cancer.
The pharmaceutical company said it took the action at the request of the U.S. Food and Drug Administration after a clinical trial raised new concerns about the product’s safety and the drug’s failure to demonstrate clinical benefit to patients enrolled in trials.
The FDA said Mylotarg (gemtuzumab ozogamicin) was approved in May 2000 to treat patients ages 60 years and older with recurrent acute myeloid leukemia who were not considered candidates for other chemotherapy. The initial approval was based on the percentage of patients whose leukemia decreased or disappeared during three clinical trials.
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004, but officials said it was halted early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
"At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal," the FDA said "This rate has increased in the post-market setting."
As a result of the withdrawal, Mylotarg will not be commercially available to new patients, the FDA said, noting patients currently receiving the drug may complete their therapy following consultation with their healthcare professional.
Posted: June 2010