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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 29, 2016
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Drugs and Targets FDA Approves Gazyva Plus Bendamustine for Patients with 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.



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