Genentech and Biogen Idec file applications for leukemia drug

Wed. May 20, 2009; Posted: 01:16 PM

May 20, 2009 (Datamonitor via COMTEX) -- DNA | Quote | Chart | News | PowerRating -- Genentech, a biotechnology company, and Biogen Idec, a biologics company, have submitted two supplemental biologics license applications to the FDA for Rituxan plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia.

The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.

The supplemental biologics license applications (sBLAs) are based on positive results from two of the largest global Phase III clinical trials conducted in patients with chronic lymphocytic leukemia (CLL).

The randomized, comparative studies, known as CLL8 and Reach, showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing compared to those receiving chemotherapy alone.

Hal Barron, chief medical officer of Genentech, said: "Results from these two large studies, which involved nearly 1,500 patients, give us confidence in Rituxan's efficacy and safety in CLL. We believe the data support the potential role of Rituxan as both an initial and second-line treatment for CLL, and look forward to working with the FDA during the review period."

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