FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

New Indication for Blood Cancer Drug Wins Approval

Nov. 22, 2017
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The FDA approved a new indication for treatment of lymphoma by Genentech’s Gazyva (obinutuzumab).

The approval is for Gazyva in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma.

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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