NICE grants approval to tisagenlecleucel for patients with previously treated DLBCL

On 1 February 2019, tisagenlecleucel, a CAR T-cell therapy, was granted approval by the National Institute for Health and Care Excellence (NICE) for the treatment of adults, who did not previously respond to two or more treatments, with diffuse large B-cell lymphoma (DLBCL). This approval means tisagenlecleucel will be available on the National Health Service (NHS), with funding from the Cancer Drugs Fund (CDF).

Tisagenlecleucel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) large B-cell lymphomas.

The approval granted by NICE was based on the positive results obtained from the ongoing, pivotal, multicenter, phase II JULIET trial (NCT02445248) assessing the safety and efficacy of tisagenlecleucel, in patients with previously treated DLBCL. The phase II JULIET study demonstrated a median relapse-free survival rate of 64% and an overall survival rate of 43% at 18-months in patients with R/R DLBCL.

The prognosis for patients with DLBCL is generally poor with limited treatment options. The NICE approval of tisagenlecleucel provides the opportunity to transform the treatment of patients with R/R DLBCL.