The European Commission (EC) has approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel for the treatment of young patients with B-cell acute lymphocytic leukemia (ALL) and adult patients with diffuse large B-cell lymphoma (DLBCL). In August 2017, tisagenlecleucel became the first CAR T-cell therapy approved by the U.S. Food and Drug Administration.
The EC’s approval of tisagenlecleucel is based on results from the phase II ELIANA trial of pediatric and young adult patients with B-cell ALL, as well as the phase II JULIET trial of adult patients with DLBCL.
In ELIANA, 81 percent of patients achieved disease remission, with 80 percent of responders still in remission at six months post-infusion (p values not provided). In JULIET, patients treated with tisagenlecleucel achieved an overall response rate of 52 percent, with 40 percent of patients achieving a complete response and 12 percent achieving a partial response (p values not provided).
Tisagenlecleucel’s manufacturer, Novartis, says that the drug’s introduction across Europe will depend on payment structures and production capacity, and could vary from country to country.
Source: Novartis press release, August 27, 2018; Reuters, August 27, 2018.