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31.05.2015 03:14:59

Genentech: Gazyva Shows Benefit In Indolent Non-Hodgkin's Lymphoma

(RTTNews) - Genentech, a member of Swiss drug maker Roche Group (RHHBY.PK, ROG.SW, RO.SW), said that results from the Phase III GADOLIN study showed the Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone provided significant benefit for people with indolent non-Hodgkin's lymphoma that is refractory to Rituxan (rituximab)-based treatment.

The company noted that in the study, Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death by 45 percent, compared to bendamustine alone.

The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected safety signals identified with Gazyva.

The late-breaking data from the GADOLIN study will be featured in the official press program of the American Society of Clinical Oncology or ASCO Annual Meeting in Chicago on Saturday, May 30, at 8:00 A.M. CDT.

Genentech and Roche will submit data from this study to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration. GADOLIN is the second positive Phase III study in the Gazyva clinical development program.

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