FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Genentech Trumpets Phase III Data for Breakthrough Leukemia Drug

Jan. 8, 2014

A Phase III study of Genentech’s Gazyva, the first drug to receive the FDA’s coveted breakthrough therapy designation, found that the treatment significantly reduces disease progression and death in patients with chronic lymphocytic leukemia, Genentech said.

The first stage of the multi-center, open-label, randomized three-arm study, held with the cooperation of the German CLL Study Group, evaluated the safety and efficacy of Gazyva (obinutuzumab) plus chlorambucil against chlorambucil on its own while the second stage compared Gazyva plus chlorambucil to Rituxan plus chlorambucil.

Results of the study showed that patients treated with Gazyva lived almost a year longer without progression of disease, and that there was an almost 10-fold increase in patients achieving minimal residual disease with Gazyva as compared to Rituxan. — Lena Freund

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