TA975 · STA

Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years

Recommended for Cancer Drugs FundNovember 2018

Source documents

Final Appraisal DocumentCommittee PapersScopeScope Consultation Comments

Intervention

tisagenlecleucel (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
ELIANA (B2202)single_armIIYes
ENSIGNnot statednot stated—
B2101Jnot statednot stated—
ELIANA———

Evidence gaps

immature overall survival—Immaturity of data which does not fully support the curative nature of tisagenlecleucel
single arm evidence only—Single-arm trial design without comparator data
other—Rate of subsequent stem cell transplant following tisagenlecleucel treatment
other—The number of people who would need treatment for B-cell aplasia with intravenous immunoglobulin, and the duration of this treatment

Commercial arrangement

managed access agreement

Special considerations

Cancer Drugs Fund eligible Innovation acknowledged Equality issues raised