Roche's Gazyva is first breakthrough drug to win FDA approval

11/3/2013 | Reuters

Roche Holding obtained the FDA's approval to market Gazyva, or obinutuzumab, in combination with chlorambucil, for use in patients with previously untreated chronic lymphocytic leukemia. The approval makes obinutuzumab the first drug with "breakthrough therapy" status to receive the FDA's nod.

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