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EU Panel Backs Roche’s Rituxan Leukemia Approval

By Pharmaceutical Processing | July 24, 2009

NEW YORK (AP) — A European regulatory panel is recommending Roche Holding’s drug Rituxan be approved as a treatment for the most common type of leukemia in adults, the Swiss drugmaker said Friday. A panel of the European Union’s Committee on Human Medicinal Products said the drug should be approved, Roche said. The company is looking for approval to market the drug, in combination with chemotherapy, as a treatment for chronic lymphocytic leukemia in patients who have not responded to earlier therapies or whose cancer has returned. Chronic lymphocytic leukemia is a cancer starting in white blood cells in bone marrow. Roche said it is the most common type of leukemia in adults, and accounts for 30 to 40 percent of all forms of leukemia in Western countries. Rituxan, or rituximab, is approved as a treatment for other cancers such as non-Hodgkin lymphoma, and rheumatoid arthritis. Roche markets the drug in the EU under the name MabThera.

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