BREYANZI (lisocabtagene maraleucel) - Follicular lymphoma (FL)

The clinical benefit of BREYANZI (lisocabtagene maraleucel) 1.1-70x106 cells/mL/1.1-70x106 cells/mL dispersion for infusion is substantial in the MA indication.

Considering:

• efficacy data from a phase 2 non-comparative study, suggesting an overall response rate of 97.0% (CI95% [91.6%; 99.4%]) including 94.1% (CI95% [87.5%; 97.8%]) complete responses;
• the uncertainty regarding estimations of the relative efficacy of this treatment, given the absence of direct comparison provided and the methodological weakness of the indirect comparisons performed, in a context where a direct comparison with an available therapeutic alternative was possible;
• the safety profile marked by significant short and medium-term toxicity;
• uncertainties with respect to the clinical efficacy and safety in the longer term given follow-up limited to around 42 months;

the Committee deems that BREYANZI (lisocabtagene maraleucel), 1.1-70 x 106 cells/mL /1.1-70 x 106 cells/mL dispersion for infusion provides no clinical added value (CAV V) in the management of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.