Lupus nephritis therapy

Jul 24, 2026

Summary Lupus nephritis (LN) is a severe, often silent complication of systemic lupus erythematosus (SLE) that progressively damages kidneys without obvious early symptoms, leading to delayed diagnosis and irreversible harm. Globally, ~1.4 million people live with LN; in the US, cases are projected to reach ...

Nov 03, 2025

Roche’s GAZYVA FDA approval has already rewritten the lupus nephritis playbook — it turned a long-standing oncology B-cell drug into a validated, kidney-saving option. It proved that aggressive B-cell targeting can materially boost complete renal responses when added to standard therapy. The GAZYVA approval (driven...

Oct 27, 2025

As the lupus treatment landscape undergoes major changes, Roche is entering the US lupus nephritis market with a fresh FDA approval for its long-standing blood cancer drug, GAZYVA. On October 20, 2025, Roche’s Genentech division announced that the FDA had approved GAZYVA (obinutuzumab) for use in adults with active...

Oct 21, 2025

FDA Approves Genentech’s GAZYVA for Lupus Nephritis Genentech, a member of the Roche Group, announced that the FDA has approved GAZYVA (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval is supported by data from the Phase II NOBILITY and P...

May 05, 2025

Lupus nephritis is a serious and common complication of systemic lupus erythematosus (SLE), characterized by inflammation of the kidneys that can lead to progressive organ damage and increased mortality. Approximately one-third of adults with SLE present with lupus nephritis at diagnosis, and up to half will develo...

Sep 20, 2019

The US FDA has in a recent move granted Roche’s Gazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis. Gazyva (obinutuzumab) is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Classified as a "monoclonal antibody", Gazyva is a CD20-directed cytolytic antibody. The drug...