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FDA grants breakthrough therapy designation for new Gazyva indication

Roche's Gazyva, or obinutuzumab, approved as a treatment for
lymphoma, was granted breakthrough therapy designation for a new indication, lupus nephritis. Data supporting the status granted by the FDA was based on results from a midstage trial that showed use of Gazyva in combination with existing standard of care was superior to placebo in terms of complete renal response at 12 months.

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