DARZALEX (daratumumab), monoclonal antibody

 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.

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)