FDA Approves Venetoclax for CLL
FDA Approves Defibrotide Sodium for Hepatic Veno-Occlusive Disease
FDA Approves Crizotinib for ROS1-Positive Lung Cancer
Innovative Clinical Trial Designs Lead to New Drug Approvals
FDA Approves New Indication for Everolimus
FDA Approves New Indication for Obinutuzumab
On February 26, 2016, the U. S. Food and Drug Administration approved obinutuzumab (Gazyva® Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.