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Published on 22 June 2010

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Leukaemia drug faces withdrawal

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Pharmaceutical giant Pfizer is to withdraw a leukaemia drug from the market in the US after follow-up research showed that it failed to slow the progress of the disease.

Mylotarg was approved in 2000 by the Food and Drug Administration (FDA) in its accelerated approval scheme, which gives quicker access to drugs that show early promise. Patients older than 60 and with relapsed acute myeloid leukaemia, a bone marrow cancer, were cleared to use the drug.

However, a follow-up study last August was brought to a halt after more deaths were reported among patients being treated with Mylotarg plus chemotherapy as opposed to chemotherapy alone. The research had set out to demonstrate that adding the drug to chemotherapy treatment increased lifespan.

The drug displays a warning about veno-occlusive disease, a sometimes fatal liver condition. FDA officials said the level of reports of the disease associated with Mylotarg jumped during the period it was up for sale.

People who are currently on the drug can continue to use it if their GP approves, Pfizer said, but it will not be available to new patients. Mylotarg will be officially withdrawn from sale on October 15.

Copyright Press Association 2010
Food and Drug Administration



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