DARZALEX (daratumumab), monoclonal antibody

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Jan 31 2019

Reason for request

Inclusion

 High clinical benefit as monotherapy in relapsed and refractorymultiple myeloma, but no demonstrated clinical benefit in the therapeutic strategy.

  

  • DARZALEX has been granted marketing authorisation for monotherapy treatment of adults suffering from relapsed and refractory multiple myeloma, for whom previous treatments included a proteasome inhibitor and an immunomodulator, and whose disease progressed during the last treatment.
  • Considering the efficacy data derived from the subgroups of two phase II studies, along with the lack of comparative data, particularly versus third-line pomalidomide, DARZALEX monotherapy does not confer any clinical benefit in the therapeutic strategy.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

Avis économique

Ce produit a fait l'objet d'un avis d'efficience rendu par la commission d'évaluation économique et de santé publique le 17 janvier 2017.

DARZALEX - Avis économique (pdf)

 

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