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utologous anti CD19 transduced CD3+ cells
Granted Conditional European Marketing Authorisation for Relapsed and Refractory Mantle Cell Lymphoma
London, UK – 16 December 2020 – Kite, a Gilead Company, today announced that the European Commission has granted conditional marketing authorisation for its autologous anti CD19 transduced CD3+ cells, a chimeric antigen receptor (CAR) T cell therapy, as a treatment 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.
The conditional marketing authorisation is supported by the ongoing, multinational, single arm, Phase 2 open-label ZUMA-2 pivotal trial. This trial was conducted in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate