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Brentuximab One Step Closer to Approval

By July 15, 2011

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Last October, I reported on a new conjugated monoclonal antibody brentuximab vedotin, that was showing amazing results in clinical trials. The drug is used to treat anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma that has not responded to other therapies including stem cell transplant and is marketed under the name Adcetris.

Yesterday, a Food and Drug Advisory panel recommended accelerated approval of the medication. Under accelerated approval the manufacturer of the drug, Seattle Genetics must continue trials to ensure that the drug is safe and effective before it gets full FDA approval.

At the half-way point of the clinical trial for Adcetris, 75% of patients had some Hodgkin's response and almost a third went into complete remission.

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