FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Priority Review Granted for New Indication for Gazyva

Sept. 5, 2017
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The FDA plans to render its verdict by Dec. 23 on approval of Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, according to the drug’s developer, Genentech.

The agency is providing priority review for the sBLA.

The FDA previously approved Gazyva for use in combination with bendamustine followed by Gazyva alone for the treatment of patients with follicular lymphoma who relapsed after, or are resistant to, a rituximab-containing regimen. Prior to that, the drug was approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.

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