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 Approval for Roche Cancer Drug Brings a New Biologic Option to Lupus Nephritis
Roche’s Gazyva, which first reached the market as a blood cancer drug, has expanded its FDA approval to include treatment of the autoimmune disorder lupus nephritis. The CD20-targeting antibody can now compete against a blockbuster GSK drug that is the standard biologic therapy for the debilitating kidney condition. The post FDA Approval for Roche Cancer Drug Brings a New Biologic Option to Lupus Nephritis appeared first on MedCity News.
FDA approves Gazyva for lupus nephritis, marking ‘significant advancement’ for patients
The FDA has approved obinutuzumab for the treatment of adults with active lupus nephritis who are receiving standard therapy, making it the second biologic available for patients with the disease.The FDA additionally approved a shorter, 90-minute infusion time following the first administration of obinutuzumab (Gazyva, Genentech), an anti-CD20 monoclonal antibody, for eligible patients. After
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