Kite has announced that their Type II variation application for a new indication to the approved license for autologous anti-CD19-transduced CD3+ cells, has been validated by the EMA.
The proposed indication is for the treatment in adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukaemia (aALL).
The Type II variation is supported by data from the pivotal global, single-arm ZUMA-3 trial for adults with relapsed or refractory B-ALL. At a median follow-up of 16.4 months, 71% of treated patients achieved a complete response (CR) or CR with incomplete haematological recovery.
Dick Sundh, Head of Australia Canada and Europe for Kite, said: “ALL is a notoriously difficult blood cancer to treat in adults who have poor survival outcomes and limited treatment options when compared with children typically diagnosed with the disease.
“We are working closely with the regulatory authorities to progress our application to potentially bring the benefits of CAR T cell therapy to adult patients in Europe, with anticipated approval in 2022.”
ALL is an aggressive blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system, and other organs. Globally over 64,000 people are diagnosed with ALL each year and while ALL incidence rates are four times higher in children than adults, survival is particularly poor among adults.
In December 2020, the European Commission granted conditional Marketing Authorisation for autologous anti-CD19-transduced CD3+ cells, the first CAR T cell therapy approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
However, the use of autologous anti-CD19-transduced CD3+ cells for the treatment of adult patients with relapsed or refractory B-ALL remains investigational in Europe.
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