Favourable opinion for maintenance of reimbursement in the “treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor”.
Clinical Benefit
Substantial
The clinical benefit of TECARTUS (brexucabtagene autoleucel) remains substantial in the MA indication.
Clinical Added Value
minor
Considering:
updated data from the ZUMA-2 study, after a median follow-up of 46.4 months, demonstrating a median overall survival of 46.5 months in the ITTm population and 43.9 months in the ITT population, in a life-threatening clinical situation;
additional experience with respect to the real-world data for TECARTUS (brexucabtagene autoleucel) from the French DESCAR-T registry (27 activated centres, 152 treated patients, median follow-up of 14.2 months since eligibility);
and despite:
updated data from the ZUMA-2 study, demonstrating differences with respect to real-world use data;
a median overall survival of 43.9 months in the ZUMA-2 study (median follow-up of 46.4 months) versus 19.8 months for the DESCAR-T registry (median follow-up of 14.2 months);
a median response duration of 2 monthsversus 12 months for the DESCAR-T registry;
uncertainties with respect to the transposability of the findings given the potentially selected population in the ZUMA-2 study;
uncertainties relative to maintenance of efficacy in the long term;
the safety profile marked by significant short-term toxicity;
the Committee considers that, on the basis of currently available data, TECARTUS (brexucabtagene autoleucel) provides a minor clinical added value (CAV IV) in terms of efficacy compared to the current treatment of relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.
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