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Biotech / Medical : Seattle Genetics (SGEN)

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From: idos	1/21/2009 12:59:17 PM
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Seattle Genetics, FDA agree on cancer study design finance.yahoo.com Seattle Genetics plans on moving cancer drug into pivotal study following deal with FDA BOTHELL, Wash. (AP) Wednesday January 21, 2009 -- Seattle Genetics Inc. said Wednesday it reached an agreement with the Food and Drug Administration to conduct a pivotal study on the cancer drug candidate SGN-35. The drug is being developed as a potential treatment for relapsed or refractory Hodgkin lymphoma, a cancer that affects the white blood cells. Under a special protocol agreement, the study will involve 100 patients with the condition who have previously received a type of stem cell transplant. The goal will be patients' response rate to the drug. The company hopes to start the study in the first quarter and expects to apply for FDA approval in 2011, under an accelerated plan. Seattle Genetics also said it plans to open a midstage study on the drug aimed at another type of cancer during the first quarter. That condition is called refractory systemic anaplastic large cell lymphoma, and is a type of immune system cancer that also involves white blood cells.

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