publication date: Feb. 26, 2016

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.

The median duration of response was not reached for those receiving the Gazyva regimen and was 11.6 months for those receiving bendamustine alone.

The Gazyva regimen reduced the risk of death by 38 percent compared to bendamustine alone based on a post-hoc analysis with 24.1 months of median observation time (HR=0.62, 95 percent CI 0.39-0.98). The median OS has not yet been reached in either study arm.

Gazyva is sponsored by Genentech. The supplemental Biologics License Application based on these data was granted Priority Review by FDA.

“People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing … Continue reading 42-08 FDA Approves Gazyva in Follicular Lymphoma

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