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FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis

Gazyva showed a 46.4% complete renal response rate in phase III trials, offering a new treatment option to reduce progression to end-stage kidney disease in lupus nephritis patients.

  • In Basel, Roche said the U.S. Food and Drug Administration approved Gazyva/Gazyvaro for adults with active lupus nephritis, with eligible patients receiving a shorter 90-minute infusion after the first dose.
  • Because current therapies leave many progressing, lupus nephritis is a potentially life‑threatening condition causing irreversible nephron loss, affecting over 1.7 million people, mostly women of colour and people of childbearing age.
  • The FDA reviewed results from the REGENCY trial, enrolling 271 people, which showed 46.4% complete renal response with Gazyva plus standard therapy versus 33.1%.
  • Clinicians treating lupus nephritis may now have a more convenient option since, after four initial doses in year one, Gazyva can be administered twice yearly.
  • Mechanistically, Gazyva is a Type II monoclonal antibody targeting CD20 B cells, received Breakthrough Therapy Designation in 2019, and the EMA's CHMP gave a positive opinion with an EC decision expected soon.
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FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct 20, 2025-

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Business Wire broke the news in Crystal River, United States on Monday, October 20, 2025.
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