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The Cancer Letter Inc.
PO Box 9905
Washington
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: Feb 26, 2016
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FDA Approves Gazyva in Follicular Lymphoma 

 

FDA approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.

The approval is based on results from the phase III GADOLIN study, which showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy, Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52 percent reduction in the risk of disease worsening or death (HR=0.48, 95% CI 0.34-0.68, p<0.0001), compared to bendamustine alone, as assessed by an independent review committee.

In addition, best overall response for those receiving the Gazyva regimen was 78.7 percent (15.5 percent CR, 63.2 percent PR) compared to 74.7 percent for those receiving bendamustine alone (18.7 percent CR, 56 percent PR), as assessed by IRC.



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