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GAZYVARO (obinutuzumab), type II humanised anti-CD20 recombinant monoclonal antibody

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Nov 12 2015

Reason for request

Inclusion

Moderate improvement in the treatment of previously untreated chronic lymphocytic leukaemia in patients with comorbidities making them unsuitable for full-dose fludarabine-based therapy.

  • GAZYVARO in combination with chlorambucil has Marketing Authorisation for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have not previously been treated and have comorbidities making them unsuitable for full-dose fludarabine-based therapy.
  • Its efficacy has been shown in a study versus rituximab plus chlorambucil (R-Clb) and chlorambucil alone in terms of progression-free survival and the rate of residual disease, but without there being any demonstrated gain in overall survival.
  • In combination with chlorambucil, the toxicity of the dual therapy containing GAZYVARO was greater than that containing rituximab. This toxicity was mainly haematological or infusion-related reactions.

 


Actual benefit

Important

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Improvement in actual benefit

III (modéré)

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Ce produit a fait l'objet d'un avis d'efficience rendu par la Commission d'évaluation économique et santé publique rendu le 13 février 2018.

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