Roche's (RHHBY) Genentech Receives FDA Breakthrough Therapy Designation for Alecensa in ALK-Positive NSCLC
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Genentech (RHHBY) Receives FDA Breakthrough Therapy Designation for Actemra as Giant Cell Arteritis Treatment
October 5, 2016 6:20 AM EDTGenentech, a member of the Roche Group (OTC: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra® (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The disease is caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.1
The FDA Breakthrough Therapy Designation for GCA underscores our continued commitment to explore Actemra in autoimmune diseases with significant unmet need, said Sandra Horning, M.D., chief... More