Cellectis’ UCART19 receives Advanced-Therapy medicinal Product classification from EMA
Published on June 23, 2014
June 23, 2014 – Paris (France) – Cellectis (Alternext: ALCLS.PA), a leader of allogeneic CAR T-cell therapies, is pleased to announce it received a Scientific recommendation from the European Medicines Agency (EMA), in consultation with the European Commission, for UCART19, its lead product candidate in adoptive immunotherapy against CD19 expressing leukemias and lymphomas.
UCART19 fulfills the definition of an Advanced-Therapy medicinal Product (ATmP) being eligible for Scientific Advices and Assessment from the EMA Committee for Advanced Therapies (CAT) as well as for European centralized Marketing Authorization Approval.
The EMA/CAT considers that Cellectis’ allogeneic engineered Chimeric Antigen Receptor (CAR+) T-cells fall within the definition of a Gene Therapy Medicinal Product.
Furthermore, Cellectis qualifies for the incentives available to Small and Medium size Enterprises (SME) developing ATmP.