- Gazyvaro® (obinutuzumab) in combination with bendamustine (chemotherapy) followed by obinutuzumab maintenance for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Comments attributable to Richard Erwin, General Manager, Roche UK:
"Gazyvaro® is one of the first in a series of innovative therapies that are expected to be considered by NICE this year via the new appraisal process for cancer medicines, and it could make a significant difference to patient outcomes across England.
"This decision from NICE is encouraging in terms of the flexibility of the new NICE and Cancer Drugs Fund system, where collecting the right data across a realistic time-frame, in this case four years, is the key to demonstrating the value of Gazyvaro in the long-term.
"We at Roche believe that patients in England should have the best access to medicines in Europe, and this development underlines our commitment to this. We have worked tirelessly with NICE to ensure that those patients who need Gazyvaro can receive it and we are delighted with this outcome."
Supporting Information
Gazyvaro is the first glyco-engineered Type II anti-CD20 monoclonal antibody licensed for the treatment of blood cancer, and has been specifically designed by scientists, through the modification of specific sugars in the antibody, to attack blood cancers more aggressively than Type I anti-CD20s.2 An example of a Type I antibody currently licensed for FL is rituximab.
Gazyvaro seeks out the ‘CD20’ protein on the surface of B-cells, which are the cells affected in the development of FL. Once Gazyvaro has located CD20 and attached to the B-cell, it can destroy the cell in two main ways:
- It can cause direct cell death2,3
Scientists have found that Gazyvaro can cause what is known as ‘direct cell death’, where the B-cell self-destructs once it comes into contact with Gazyvaro
- It can recruit the body’s immune system to attack and destroy the cell4
The immune system attacks ‘foreign invaders’ in the body, but it doesn't always recognise cancer cells as enemies. By marking out B-cells, Gazyvaro signals immune cells to attack and destroy them, helping the immune system to fight cancer more effectively. This process is known as ‘antibody-dependent cellular cytotoxicity’, or ADCC
In addition to the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen, Gazyvaro is also licensed for use in combination with chlorambucil for the treatment of previously-untreated adult patients with chronic lymphocytic leukaemia (CLL) and co-existing medical conditions unsuitable for full-dose fludarabine-based therapy.
GADOLIN data
GADOLIN is a Phase III open-label, multicentre, randomised study evaluating the safety and efficacy of Gazyvaro (obinutuzumab) plus bendamustine, followed by Gazyvaro maintenance compared with bendamustine alone in 396 patients with FL whose disease progressed during or up to 6 months after rituximab-based prior treatment. The primary endpoint of the study is IRC-assessed progression free survival (PFS), with secondary endpoints including response rates and overall survival (OS).7
GADOLIN was trialed at five centres throughout the UK, including:
- St Bart’s Hospital, London
- Beatson West of Scotland Cancer Centre, Glasgow
- Freeman Hospital, Newcastle
- Leicester Royal Infirmary, Leicester
- Singleton Hospital, Swansea
About Roche
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life, safety and survival of patients. Twenty-nine medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. Roche in the UK employs over 2,000 people in pharmaceuticals and diagnostics.
All trademarks used or mentioned in this release are protected by law.
Adverse reaction reporting
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Roche is committed to the safety of its medicines. As such Roche encourages Adverse Events to be reported and hence the inclusion of this explanatory information. Adverse events should also be reported to Roche Products Ltd.
National Institute for Health and Care Excellence. Final appraisal determination. Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab. July 2017
Mössner E, Brünker P, Moser S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell mediated B-cell cytotoxicity. Blood 2010; 115:4393−4402.
Alduaij W, Ivanov A, Honeychurch J, et al. Novel type II anti-CD20 monoclonal antibody (GA101) evokes homotypic adhesion and actin-dependent, lysosome-mediated cell death in B-cell malignancies. Blood 2011; 117:4519−4529.
Niederfellner G, Lammens A, Mundigl O, et al. Epitope characterization and crystal structure of GA101 provide insights into the molecular basis for type I/II distinction of CD20 antibodies. Blood 2011: 118:358−367.
Mayo Clinic. Monoclonal antibody drugs for cancer: how they work.
Gazyvaro (obinutuzumab). Summary of Product Characteristics. 22 June 2016.
Sehn, Laurie H et al. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. The Lancet Oncology 2016: Volume 17, Issue 8, 108-1093
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