Obinutuzumab

Key takeaways

Obinutuzumab belongs to biology; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Obinutuzumab to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Obinutuzumab from memory before moving on to harder problems.

Reference excerpt

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.

Medical uses 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. 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.

Side effects 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.

Chemistry Obinutuzumab is a fully humanized monoclonal antibody that binds to an epitope on CD20 that partially overlaps with the epitope recognized by rituximab. GlycArt's technology platform allowed control of protein glycosylation; the cells in which obinutuzumab is produced were engineered to overexpress two glycosylation enzymes, MGAT3 and Golgi mannosidase 2, which reduce the amount of fucose attached to the antibody, which in turn increases the antibody's ability to activate natural killer cells. Details of the antibody's structure are disclosed in the 2008 WHO INN naming proposal.

History Obinutuzumab was created by scientists at GlycArt Biotechnology, which had been founded in 2000 as a spin-out company of the Swiss Federal Institute of Technology in Zurich to develop afucosylated monoclonal antibodies; GA101 was one of its lead products when it was acquired by Roche in 2005. Roche developed the drug in the US through its US subsidiary, Genentech, and in Japan through its Japanese subsidiary, Chugai. Genentech partnered with Biogen Idec to explore the use of the drug for primary biliary cirrhosis but as of 2014 it appeared the development in that indication had halted. In November 2013, the US Food and Drug Administration (FDA) approved obinutuzumab in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia, and was the first drug with breakthrough therapy designation to gain approval. In October 2014, NICE announced that NHS England would not fund use of the drug, due to data uncertainties in Roche's application. In June 2015, NICE announced that it would fund restricted use of the drug. In their final recommendation of obinutuzumab, in the January 2015 Pan-Canadian Oncology Drug Review (pERC) for treatment of chronic lymphocytic leukemia, published by the Canadian Agency for Drugs and Technologies in Health, the list price of obinutuzumab provided by the manufacturer Hoffmann-La Roche was $CDN 5,275.54 per 1,000 mg vial. At the recommended dose obinutuzumab costs $15,826.50" for the first 28-day cycle and "$5275.50 per 28 day cycle for subsequent cycles." In February 2016, obinutuzumab was approved by the FDA under the Priority Review program for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma as a secondline treatment to a regimen containing rituximab. In January 2019, the US Food and Drug Administration (FDA) approved ibrutinib in combination with obinutuzumab for people with chronic lymphocytic leukemia/small lymphocytic lymphoma who have not received prior treatment. In October 2025, the US Food and Drug Administration (FDA) approved obinutuzumab for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, making it the first anti-CD20 monoclonal antibody approved for this indication.

Research

Chronic lymphocytic leukemia As of 2014 clinical trials had been conducted exploring the use of obinutuzumab as a second line monotherapy in relapsed/refractory chronic lymphocytic leukemia, as a monotherapy for relapsed/refractory non-Hodgkin lymphoma in people who had high expression of CD20; and in combination with CHOP chemotherapy as a first line treatment for people with advanced CD20-positive diffuse large B-cell lymphoma. It was called GA101 during research.

Nephropathies 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.

References

External links "Obinutuzumab". NCI Dictionary of Cancer Terms. National Cancer Institute. "Obinutuzumab". National Cancer Institute. 12 November 2013.

Worked examples

Example 1 — a first encounter with Obinutuzumab

Start with the simplest possible case. Write down what Obinutuzumab claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In biology, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Obinutuzumab before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Obinutuzumab ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Obinutuzumab

In research: Obinutuzumab appears in biology research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Obinutuzumab in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Obinutuzumab is common in secondary-school and first-year university syllabi. It links to neighbouring topics Drugs developed by Genentech, Drugs developed by Hoffmann-La Roche, Monoclonal antibodies for tumors, so understanding it makes those chapters shorter.
In everyday life: Look for Obinutuzumab outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

How to study Obinutuzumab in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Obinutuzumab means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Obinutuzumab out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Obinutuzumab in simple terms?

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.

Why does Obinutuzumab matter?

Because it connects several biology ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Obinutuzumab?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Obinutuzumab.