Leukemia drug Mylotarg taken off the market over safety, effectiveness concerns

For patients with a diagnosis of the blood cancer acute myeloid leukemia, or AML, the search for a drug that can effectively treat a recurrence of leukemia has been elusive. So the withdrawal from the market Monday of the AML drug gemtuzumab ozogamicin, marketed as Mylotarg, comes as another disappointment to those hoping for a cure.

Pfizer, which makes Mylotarg, withdrew the drug after a clinical trial raised concerns about its safety and effectiveness. Early trials had spurred hopes that Mylotarg would induce remission -- meaning the absence of leukemia in the bone marrow -- in almost a third of patients who took it. But the drug, which promised reduced side effects because it appeared to home in only on cancerous cells, has been associated with a serious and sometimes fatal liver condition call veno-occlusive disease.

Although Mylotarg received accelerated FDA approval in 2000, the agency required an additional clinical trial to demonstrate its safety and effectiveness. That trial, which began in 2004, has shown higher levels of liver toxicity in patients than seen in early trials, with no benefits to patients. In fact, compared with AML patients on standard chemotherapy alone, those on Mylotarg were more likely to die.

The FDA said that patients who have begun treatment with Mylotarg may complete their therapy, but that patients with new recurrences of AML will not be permitted to start on the medication.

Remember that some patients with AML can be treated -- and cured -- with a bone marrow transplant, but they need an excellent match for a good outcome. Joining the bone marrow registry is easy and painless, and you could be the match that saves someone's life. Find out why and how to register as a prospective bone marrow donor here.

-- Melissa Healy

Comments

[Winfield J. Abbe]

Another dismal failure of the war on cancer. Obviously the cancer generals do not know what they are doing. How long will dumbed down Americans continue to put up with this nonsense. Cancer treatment, mistreatment would be a more appropriate word, is the biggest scam in the world. The medical orthodoxy is engaged in medical quackery, but if others do it they are harassed and prosecuted. Everyone should read "The Truth About Hydrazine Sulfate-Dr. Gold Speaks" by Joseph Gold, M.D. at www.hydrazinesulfate.org. This document is basically a criminal indictment of the NIH, NCI and FDA and shows how our government agencies actually post lies on a government website. The cancer generals must not only be fired immediately, but prosecuted for scientific misconduct, fraud, medical quackery and crimes against humanity. Wake up you dumbed down Americans. Next time it may be you or your loved one who is killed by the medical quacks in the U.S.