BRUKINSA (zanubrutinib) - Marginal zone lymphoma (MZL)
Opinions on drugs -
Posted on
Jul 27 2023
Reason for request
Inclusion
Primo-inscription.
L'essentiel
Avis favorable au remboursement de la spécialité dans l’indication : « BRUKINSA en monothérapie est indiqué pour le traitement de patients adultes atteints de lymphome de la zone marginale (LZM) ayant reçu au moins un traitement antérieur à base d’anticorps anti-CD20 ».
Quel progrès ?
Pas de progrès dans la stratégie de prise en charge.
Quelle place dans la stratégie thérapeutique ?
BRUKINSA (zanubrutinib) est une option de traitement dans la prise en charge du lymphome de la zone marginale (LZM) en rechute après un traitement à base d’anticorps anti-CD20.
Clinical Benefit
Substantial
The clinical benefit of BRUKINSA (zanubrutinib) is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the impossibility of drawing formal conclusions concerning the effect size of the treatment compared to the available alternatives given:
the weakness of demonstration of its efficacy (data from a phase II, non-comparative study), with a primary endpoint (overall response rate) that is not the most relevant in the context of an indolent disease;
the small size of the study populations (n = 66), associated with a limited median follow-up period;
the absence of a formal conclusion that can be drawn from the results for progression-free survival, overall survival and quality of life given their exploratory and non-comparative nature;
the safety profile of BRUKINSA (zanubrutinib) marked by grade 3 and more adverse reactions in 48.5% of patients and serious adverse reactions reported in 41.1% of patients;
interpretation limitations surrounding the indirect comparison provided;
the Committee deems that BRUKINSA (zanubrutinib) provides no clinical added value (CAV V) in the current care pathway in adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
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