Mylotarg withdrawn from market

Leukemia drug gemtuzumab ozogamicin (Mylotarg) was voluntarily withdrawn from the U.S. market last week by manufacturer Pfizer, according to an announcement from the FDA.

The withdrawal was requested by the FDA after results from a recent clinical trial raised safety concerns, including an association with veno-occlusive disease, and the drug failed to demonstrate clinical benefit to patients.

The drug had been approved in May 2000 under the accelerated approval program for patients with acute myeloid leukemia. Under accelerated approval, manufacturers are required to conduct additional clinical trials after approval to confirm the drug's benefit. Since it's been withdrawn, the drug will no longer be commercially available to new patients. Those who are currently receiving it may complete their therapy following consultation with their health care professional.