EMA Recommends CAR T-Cell Therapies for Approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve two chimeric antigen receptor (CAR) T-cell therapies that were approved by the U.S. Food and Drug Administration (FDA) in 2017.

Receiving this decision from CHMP is a key step toward allowing these products to be used throughout Europe.

In the case of tisagenlecleucel, the recommendation was granted for treatment of B-cell acute lymphocytic leukemia and diffuse large B cell lymphoma (DLBCL), applications for which it already received FDA approval. Axicabtagene ciloleucel was given preliminary approval for treatment of DLBCL and primary mediastinal B cell lymphoma. Both therapies rely on CAR T-cell technology, which allows doctors to harvest patient cells, reengineer them to target cancer, and reintroduce the cells back into the patient’s immune system.

Along with these decisions, CHMP also issued a recommendation of approval for the interleukin-6 receptor tocilizumab, which is used to manage cytokine release syndrome, a potentially fatal adverse event associated with CAR T-cell therapies. Because CHMP recommendations are usually followed by the European Commission, the ruling indicates that these treatments could be available in Europe within months.

Source: Reuters, June 29, 2018.