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Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complication

June 11, 2019 / Eric Sagonowsky

One brand-new FDA approval and one trial win for its blood cancer drug Gazyva added up to a double dose of good news for Roche Monday. The Swiss drugmaker snapped up a combo approval for lymphoma drug Polivy, then touted Gazyva trial results in a completely different field: lupus nephritis, a potentially fatal complication of the autoimmune disease systemic lupus erythematosus. In a phase 2 study, adding Gazyva to standard lupus nephritis treatment beat that standard of care alone alone at delivering complete renal responses at one year. The drug also hit key secondary goals. There are no drugs specifically approved to treat lupus nephritis. The standard of care used in the trial combined one of two immunosuppressant drugs approved for organ transplant patients—CellCept or Myfortic—with corticosteroids and placebo. Roche plans to present the full data at an upcoming meeting.