FDA Approves Gazyva™ (Obinutuzumab) for People With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Industry News

The U.S. FDA has granted Orphan Drug Designation to Gazyva™ (obinutuzumab), a monoclonal antibody developed by Genentech, a member of the global pharmaceutical company Roche, for the treatment of splenic marginal zone lymphoma (SMZL).  SMZL is a rare form of non-Hodgkin lymphoma and is considered a low-grade lymphoma with B-cell origin.  A small percent of SMZL patients with blastic transformation have poor response to treatment and survival.  Gazyva is a monoclonal antibody designed to bind to CD20, a protein found only on B-cells.  It can attack CD20-expressing B-cells both directly and in collaboration with the body’s immune system as an immune modulator.  It is approved for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil.



  1. http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinutuzumab-for-peo
  2. http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6554677
  3. http://www.bloodjournal.org/content/bloodjournal/101/7/2464.full.pdf?sso-checked=true

Subscribe to WXPress

Receive our newsletter and information on upcoming events.