Breaking News, Trials & Filings

Gazyva Approved for CLL

Roche/Genentech antibody first Breakthrough Therapy cleared by agency

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has approved Roche/Genentech‘s Gazyva (obinutuzumab), in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL). Gazyva is the first medicine approved with the FDA’s Breakthrough Therapy Designation and the fifth cancer medicine from Genentech approved by the FDA in the past three years. The FDA granted Gazyva Breakthrough Therapy Designation due to the significance of the positive progression-free surviv...

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