Gazyva
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD20 |
| Clinical data | |
| Trade names | Gazyva (US), Gazyvaro (EU) |
| License data | |
| Routes of administration |
Intravenous infusion |
| ATC code | |
| Legal status | |
| Legal status |
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| Pharmacokinetic data | |
| Biological half-life | 28.4 days |
| Identifiers | |
| CAS Number | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6512H10060N1712O2020S44 |
| Molar mass | 146.1 kg/mol |
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Obinutuzumab (called afutuzumab until 2009, originally GA101) is a humanized anti-CD20 monoclonal antibody, originated by GlycArt Biotechnology AG and developed by Roche as a cancer treatment. It was approved under the trade name Gazyva by the US FDA in 2013, and as Gazyvaro by the EMA in Europe, for the treatment of chronic lymphocytic leukemia in combination with chemotherapy in treatment-naive patients, and as a second line treatment for follicular lymphoma.
Obinutuzumab is used in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia. Its progression-free survival is better than rituximab in the same combination (26.7 months vs. 15.2 months) but its overall survival rate is not better (8% vs. 12%). It is also used in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma as a second line treatment to a regimen containing rituximab.
It was not tested in pregnant women, and is Pregnancy Category C.
Obinutuzumab has two black box warnings: hepatitis B reactivation and progressive multifocal leukoencephalopathy.
In the pivotal clinical trial of obinutuzumab in combination with chlorambucil, clinical trial subjects 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.
There is a risk of thrombocytopenia and hemorrhage with obinutuzumab, consideration should be given to withholding medications that may increase the risk of bleeding.
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