- Date 08 March 2017
- Documents : 4
- Economic analysis
- History
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GAZYVARO (obinutuzumab), monoclonal antibody
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Sep 06 2017
Reason for request
Extension of indication
No clinical benefit demonstrated in combination with bendamustine followed by Gazyvaro 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
- GAZYVARO now has Marketing Authorisation as part of a therapeutic strategy in patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
- The therapeutic strategy of GAZYVARO + bendamustine (induction) followed by maintenance treatment with GAZYVARO improved progression-free survival compare to treatment with bendamustine alone in patients with indolent non-Hodgkin lymphoma in early relapse and in patients with follicular lymphoma.
- No improvement in overall survival has been demonstrated.
- Many issues have been raised regarding the study design which could favor the GAZYVARO arm relative to the bendamustine arm.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
-
Economic analysis
English version
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