Gazyva™ (Obinutuzumab) granted Orphan Drug Designation by FDA for treatment of follicular lymphoma

Industry News

Obinutuzumab was granted Orphan Drug Designation by the FDA for the treatment of follicular lymphoma.  Obinutuzumab (Gazyva) is a monoclonal antibody against CD20, a protein found only on B-cells.  Genentech, a member of the Roche group based in South San Francisco, CA, currently markets Gazyva.  Gazyva was approved for treatment of chronic lymphocytic leukemia (CLL) in 2013 and was the first medicine approved with the FDA’s Breakthrough Therapy Designation.  Follicular lymphoma is one form of non-Hodgkin’s lymphoma.  Despite of its slow-growing character, most cases of follicular lymphoma are not curable with currently available therapies. According to, there are 7 active phase I/II trials ongoing to evaluate Gazyva in patients with follicular lymphoma.


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