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Obinutuzumab

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Obinutuzumab

Obinutuzumab, sold under the brand name Gazyva among others, is a humanized anti-CD20 monoclonal antibody used as a treatment for cancer and active lupus nephritis. It was originated by GlycArt Biotechnology AG and developed by Roche.[citation needed]

As of 2015, obinutuzumab was being used in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia. One more recent study has shown deeper and longer-lasting remissions through fixed-duration treatment regimens in combination with venetoclax.[non-primary source needed]

It is also used in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of people with follicular lymphoma as a second line treatment to a regimen containing rituximab.

Obinutuzumab was not tested in pregnant women.

Obinutuzumab has two black box warnings: hepatitis B reactivation and progressive multifocal leukoencephalopathy.

In the clinical trial of obinutuzumab in combination with chlorambucil, participants experienced infusion reactions (69%; 21% grade 3/4), neutropenia (40%; 34% grade 3/4), thrombocytopenia (15%; 11% grade 3/4), anemia (12%), and pyrexia and cough (10% each). More than 20% of subjects had abnormal lab tests including low calcium and sodium, high potassium, increases in serum creatinine and liver function tests, and low albumin levels.

Obinutuzumab is recently reported to be safe and effective in some autoimmune diseases affecting the kidneys. It is a promising treatment of renal diseases with proteinuria, in particular patients with resistance or partial response to rituximab. A single low-dose infusion of obinutuzumab, found to be effective and safe in inducing prolonged remission in children with steroid-dependent or frequently relapsing nephrotic syndrome. This effect is particularly shown in children who have rituximab resistance or relapse after rituximab. The tolerance profile of obinutuzumab is comparable to rituximab. Similar promising results is shown in adults with membranoproliferative glomerulonephritis treated with obinutuzumab after resistance to rituximab, tacrolimus and cyclophosphamide. Furthermore, obinutuzumab showed sustained clinical benefit through 2 years in patients with class III and IV Proliferative Lupus Nephritis compared to rituximab.

Obinutuzumab is a fully humanized monoclonal antibody that binds to an epitope on CD20 that partially overlaps with the epitope recognized by rituximab.

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