The big news from the American Society of Hematology


There were several big studies that were presented at the 2011 annual meeting of the American Society of Hematology, including many early phase studies in lymphoma, leukemia and myeloma.One of the surprising studies that came out included a phase 3 study of a drug that was withdrawn from the market last year called Mylotarg. It appears that it may have a second life after researchers tweaked the dose for older patients with acute myeloid leukemia.Mylotarg, also known as gemtuzumab ozogamicin, was approved back in 2000 for relapsed AML, but was withdrawn when follow-up studies showed the drug did not improve response rates and also increased the risk of a rare, but life-threatening liver complication called VOD (veno-occlusive liver disease). A French group tested the drug in a phase 3 trial using a modified dosing regimen that was easier on patients, which reduced side effects and significantly improved survival. Newly diagnosed patients aged 50 to 70 years who received standard chemotherapy with 3 mg/m2 three times a week lived longer than patients on chemotherapy alone (19.2 months versus 34 months). "With the lower dose, we have less toxicity ... and we have more efficacy," says Sylvie Castaigne, MD, lead investigator of the ALFA study. She said this recent study included fewer deaths from VOD than in the past studies, but that patients also experienced low platelet counts, however that side effect was manageable.Several ongoing trials with Mylotarg may show the drug still has a place in AML treatment. The drug's maker, Pfizer, is waiting for additional study results before determining whether to resubmit the drug to the FDA for approval. "At this point, we are trying to better understand the data out there in hopes that they indeed look as good as we would like them to look," says Mark Shapiro, MD, PhD, a senior director of global medical affairs with the drug company. "Pfizer is definitely interested, the issue is what can we do with this data."Because the drug has been withdrawn, it is typically not available to most patients. However, it is still being studied in clinical trials. Additionally, there are other studies looking at a second-generation drug called inotuzumab ozogamicin.You can read more from ASH from Dr. Anas Younes (Studies highlight progress in lymphoma, pose more questions) and other stories on lymphoma, myeloma and leukemia in our News section.

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