Obinutuzumab
| Obinutuzumab | ||
|---|---|---|
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| Two identical dimers of the GA101-Fab fragment ( Mus musculus ) as a band model, according to PDB 3PP3 | ||
| Mass / length primary structure | 146 kDa | |
| Identifier | ||
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| Drug information | ||
| ATC code | L01 XC15 | |
| Drug class | Cytostatic , monoclonal antibody | |
Obinutuzumab (old name Afutuzumab , trade name Gazyvaro ® or outside the EU as Gazyva ® ; manufacturer Roche ) is a humanized monoclonal antibody that is used to treat therapy-resistant chronic lymphatic leukemia (CLL) and / or follicular lymphoma (FL) , the most common type the indolent (slow-growing) non-Hodgkin's lymphoma (NHL) can be used.
Mode of action
GA101 (obinutuzumab) acts as a CD20 antibody similar to rituximab and ofatumumab . This active ingredient is the first monoclonal CD20 antibody of the 2nd generation, which has been optimized using the so-called glycoengineering ( glycosylation ) technique . This can improve the destruction of malignant B lymphocytes by activating other immune cells against cancer cells or by directly triggering cell death.
Admission status
In the USA, an accelerated approval process took place due to the expected good results . In November 2013, Gazyva ® was approved by the FDA in combination with chlorambucil for the treatment of previously untreated CLL. In July 2014, Gazyvaro ® was approved in the EU for the treatment of patients with previously untreated CLL. For Europe, the CHMP recommended approval in the FL indication to the European approval authority EMA in April 2016. Approval can usually be expected afterwards.
Studies
A German study with 781 patients showed that obinutuzumab achieved better results in the treatment of comorbid patients with CLL compared to rituximab . On average, the progression-free survival time could be extended by 10 months by replacing the former with obinutuzumab in the standard therapy rituximab and chlorambucil . However, infusion reactions and neutropenia were more common with obinutuzumab .
history
GA-101 was developed by Glycart Biotechnology AG, Genentech , Hoffmann-La Roche , Biogen Idec and Chugai Pharmaceutical .
dosage
In a phase III study of the German CLL study group, GA101 is combined with chlorambucil : 1000 mg GA101 intravenously on days 1, 8 and 15 (cycle 1) and day 1 (cycle 2–6) and 0.5 mg chlorambucil / kg Body weight orally on days 1 and 15 of each cycle.
See also
- Monoclonal Antibody Nomenclature : Convention for naming monoclonal antibodies
Web links
- American Society of Hematology (ASH) , as of 12/2010
- German CLL study group
Individual evidence
- ↑ FDA approves Gazyva for chronic lymphocytic leukemia , PM FDA dated November 1, 2013, accessed July 30, 2014
- ↑ a b Roche's Gazyvaro approved in Europe for patients with the most common type of leukemia ( Memento of the original dated August 2, 2014 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. , Roche PM July 29, 2014, accessed July 30, 2014
- ↑ CHMP recommends EU approval for Roche's Gazyvaro for patients with previously treated follicular lymphoma , Roche PM April 29, 2016, accessed May 1, 2016
- ↑ Valentin Goede, Kirsten Fischer, Raymonde Busch, Anja Engelke, Barbara Eichhorst, Clemens M. Wendtner, Tatiana Chagorova, Javier de la Serna, Marie-Sarah Dilhuydy, Thomas Illmer, Stephen Opat, Carolyn J. Owen, Olga Samoylova, Karl- Anton Kreuzer, Stephan Stilgenbauer, Hartmut Döhner, Anton W. Langerak, Matthias Ritgen, Michael Kneba, Elina Asikanius, Kathryn Humphrey, Michael Wenger, Michael Hallek: Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions. In: New England Journal of Medicine . 2014, 370: 1101–1110, doi: 10.1056 / NEJMoa1313984 .
- ↑ GA-101, a third-generation, humanized and glyco-engineered anti-CD20 mAb for the treatment of B-cell lymphoid malignancies. Researchgate, accessed July 9, 2014 .
