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Genentech and Biogen Idec obtain FDA complete response for leukemia drug

Posted on: Thu, 19 Nov 2009 09:53:00 EST

Symbols: DNA, BIIB

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Nov 19, 2009 (Datamonitor via COMTEX) --
DNA | Quote | Chart | News | PowerRating -- Genentech, a wholly-owned member of the Roche Group, and Biogen Idec have reported that the FDA issued a complete response on their applications for Rituxan plus fludarabine and cyclophosphamide for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia, or CLL.

These applications are based on data from two Phase III studies, CLL8 and Reach. sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated CD20-positive CLL.

Reach was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan (Rituxan-naive).

Both studies evaluated Rituxan plus fludarabine and cyclophosphamide (FC) chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity.

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