Roche Wins Approval for First Breakthrough Therapy Drug
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Roche Holding AG won approval for its Gazyva drug for patients with leukemia who haven’t been treated before.
The medicine, also known as obinutuzumab, is cleared to treat chronic lymphocytic leukemia and is the first breakthrough therapy ever to receive approval, the Food and Drug Administration said today in a statement. The FDA granted Gazyva the designation, which means preliminary evidence indicated it might offer substantial improvement over current treatment.