Pfizer’s cancer drug, Mylotarg, is no longer available after being on the U.S. market for the past 10 years. If you have a prescription drug plan, then now is the time to start looking into your health insurance carrier’s “formulary,” which is the list that includes drugs that are covered. You will need to consult with your doctor to find an appropriate alternative that is covered through your health plan.
Pfizer decided to remove the drug from the market because studies failed to prove that it has any effectiveness. Additionally, there were reported deaths from liver and lung complications linked to its use.
Mylotarg’s Use in Health Care
Mylotarg is a medication used for the treatment of relapsed myeloid leukemia. It was approved in 2000. It is the first medication pulled from the market that was cleared under the Food and Drug Administration’s accelerated approval program. Pfizer’s choice to remove of the drug from the market was voluntary after trials showed the ineffectiveness of the drug.
When the drug was first approved in 2000 it showed promising potential because it showed improved remission rates. Its approval, however, came with the requirement that more complete trails would be done to prove its effectiveness. The follow-up research didn’t begin until 2004, and the results of the trials weren’t available until this year. The studies questioned the benefits of the drug, and also revealed a possible link between the drug and a four-fold increase in the risk of death.
In 2000, Mylotarg was cleared for patients 60 years of age and older who had experienced their first relapse of acute myeloid leukemia and weren’t candidates for cytotoxic chemotherapy. Although some patients who took the drug wouldn’t be alive today had they not used the prescription, others suffered serious liver complications when they were administered the FDA-approved dosage.
Peter Marks, of Yale-New Haven Hospital said, “Since we’ve changed over to this method of using it in divided doses, we’ve really not seen any of those same complications. It just doesn’t happen. The question is, with larger studies, will that be shown to have the kind of efficacy that will be needed to convince FDA that this is a valuable drug.”
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