Gazyva trial sees increased PFS
December 2013
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BASEL, Switzerland—Roche has announced that in a Phase III trial in patients with previously untreated chronic lymphocytic leukemia, its monoclonal antibody Gazyva extended progression-free survival (PFS) by nearly a year compared to MabThera. Patients who received Gazyva saw a reduced risk of tumor growth or death of 61 percent, with an average PFS of 26.7 months, while patients who received MabThera saw a median PFS of 15.2 months. Additionally, 21 percent of patients in the Gazyva group achieved a complete response, with 29.4 percent showing no detectable disease in the blood at the end of treatment. Some 20 percent of Gazyva patients experienced an infusion-related reaction, with 33 percent experiencing neutropenia and 7 percent seeing infections. Gazyva received U.S. Food and Drug Administration approval in early November, the first approval of a drug granted breakthrough therapy status.
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