The authorization of use is limited, for the moment, to the Hospital Clínic in the preparation and administration of the drug.
The Spanish Agency for Medicines and Health Products (AEMPS) has approved the first CART in Europe developed by a Spanish public hospital: Hospital Clínic de Barcelona. This advanced therapy medicinal product is indicated for use in a subset of patients with Acute lymphoblastic leukemia.
The general director of the Hospital Clínic de Barcelona, Josep Maria Campistol, has celebrated the approval of CART ARI-0001: “It is a moment of tremendous significance and importance”.
CART is a type of cell and gene therapy in which the patient becomes his own donor and consists of modifying the patient’s T lymphocytes so that they have the ability to attack tumor cells.
The head of the Immunology Service of the hospital, Manel Juan has explained that, in this case, the CART ARI-0001 has been developed from an own antibody created in the hospital More than 30 years ago they have found “a new application”.
Trial results show that the drug produces a complete response in more than 70% of patientsAlthough this does not mean that there is no residual disease, but of these, 47% did remain disease free, Urbano-Ispizua has specified.
For his part, the head of the AEMPS Department of Medicines for Human Use, César Hernández, praised the “very important achievement of academic research” with the approval of this CART.
This authorization of use is limited to Hospital Clínic in the preparation and administration of the drug, but another nine state hospitals have been included which, if they acquire sufficient experience, may also request authorization for use.