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Genentech, Biogen Idec Gets Complete Response From FDA For Rituxan For Chronic Lymphocytic Leukemia

Genentech Inc., a unit of Roche Group (RHHBY.PK), and Biogen Idec (BIIB) said that the FDA issued a complete response on the companies' applications for Rituxan plus fludarabine and cyclophosphamide for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia.

The FDA has not requested any new data to complete its review of these applications.

Genentech and Biogen Idec said they will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.

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