If you are a cancer patient being treated with this drug, as of today it will no longer be available without a specific request sent to the FDA. The drug did not work in short and there was the side effect of liver disease related to the product. The drug was used as a treatment for bone marrow cancer.
The drug didn’t prove any benefits and had a bad potential side effect here, so this somewhat goes to show that all drugs are not helpful when the studies come in and you can bet there was a ton of time and research money spent on the development. This is another example too of why big pharma is turning toward the smaller biotech companies for development, back to the money again. BD
Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.