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RYDAPT (midostaurine), tyrosine kinase inhibitor

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Jan 28 2019

Reason for request

Inclusion

High clinical benefit in the treatment of newly diagnosed acute myeloid leukaemia with FLT3 gene mutation, combined with chemotherapy, and minor clinical added value over chemotherapy alonein terms of efficacy.

 

  • RYDAPT has been granted an MA for the treatment of adults presenting with newly diagnosed acute myeloid leukaemia (AML) with FLT3 gene mutation, combined with standard induction chemotherapy combining daunorubicin and cytarabine, along with high-dose cytarabine consolidation chemotherapy, followed, for patients in complete remission, by a maintenance treatment of RYDAPT monotherapy.

  • One study demonstrated the superiority, in terms of overall survival, of a therapeutic strategy comprising 3 midostaurin-based treatment phases over a therapeutic strategy without midostaurin. A number of uncertainties remain, however, concerning the amount of effect conferred specifically by RYDAPT insofar as the patients in both treatment groups compared may have received an autologous HSC transplantation.

 


Actual benefit

Important

-


Improvement in actual benefit

IV (mineur)

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Ce produit a fait l'objet d'un avis d'efficience rendu par la commission évaluation économique et santé publique le 22 mai 2018.

See also