16 February, 2021
The AEMPS approves the use of a CAR-T therapy developed by the Hospital Clínic Group for the treatment of a type of leukaemia
In recent years, cancer treatment has been revolutionised by immunotherapy, an approach that uses a patient’s own immune system to attack tumour cells. The Spanish Agency of Medicines and Medical Devices (AEMPS) has just approved ARI-0001, a CAR T-cell therapy (a type of immunotherapy) developed entirely by the Hospital Clínic Group, for use as a medicinal product. This is the first time that a treatment with genetically modified cells developed entirely in Europe has been approved by a regulatory agency, and it is also the first time that it has been done without the backing of a pharmaceutical company.