TA893 · STA

Brexucabtagene autoleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people 26 years and over

Recommended for Cancer Drugs FundApril 2023

Source documents

Final Appraisal DocumentAppraisal Consultation DocumentCommittee PapersScopeScope Consultation Comments

Intervention

brexucabtagene autoleucel (not stated)
· genetically modified autologous T cell immunotherapy (CAR-T cell therapy) · infusion

Condition

relapsed or refractory b-cell acute lymphoblastic leukaemiahaematology · relapsed_refractory

Clinical trials

TrialDesignPhasePivotal
ZUMA-3single_armPhase 2Yes

Evidence gaps

immature overall survival—Overall survival data are not yet mature. Longer-term overall survival from clinical trial is required.
other—Relapse-free survival and cure assumption. Key area of uncertainty identified by committee.

Commercial arrangement

managed access agreement · confidential · critical for recommendation

Special considerations

Cancer Drugs Fund eligible Equality issues raised