Pfizer has agreed to voluntarily pull a leukemia drug off the market for not slowing the disease and failing to increase survival. The decision comes after a follow-up study was stopped last August because when the leukemia drug, Mylotarg, was used along with chemotherapy, researchers reported more patient deaths when compared to patients only receiving chemotherapy.
Mylotarg was approved for patients older than 60 with relapsed acute myeloid leukemia, a bone marrow cancer. The follow-up study was intended to show that Mylotarg would extend life when added to chemotherapy, which it did not. In addition, Mylotarg had a warning label about the drug causing veno-occlusive disease, a sometimes fatal liver disease. After the drug went to market, the incident rate of patients developing the liver disease increased.
The Associated Press (AP) reported that about 2,500 US patients receive Mylotarg each year and about 13,000 are affected each year by acute myeloid leukemia. Patients receiving Mylotarg can remain on the drug if their doctors approve. Dr. Mikkael Sekeres of the Cleveland Clinic said that about 25 to 30 percent of his patients using Mylotarg went into remission, but that the drug’s benefits bring increased toxicity.
If someone you know has suffered veno-occlusive disease, a sometimes fatal liver disease after taking Mylotarg , please contact Sheller, P.C. at 1-800-883-2299.