After touting Gazyva's potential in lupus, Roche nabs 'breakthrough' ahead of PhIII

Roche’s effort to introduce its blood cancer drug Gazyva to the immunology space just got a boost from the FDA.

Regulators have granted breakthrough designation to the use of the CD20-targeting antibody in lupus nephritis, a life-threatening manifestation of systemic lupus erythematosus in the kidney. Up to 60% of all people with lupus — disproportionately women — develop such inflammation in the kidney, the Lupus Foundation of America estimates.