The European Medicines Agency (EMA; London, UK) has recommended marketing authorizations for two chimeric antigen receptors (CAR)-T cell therapies, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), in a Europe first. Kymriah (Novartis; Switzerland) and Yescarta (Kite, a Gilead company; CA, USA) are also the first medicines supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced support for therapies that significantly address an unmet need, to receive positive opinions from the Committee for Medicinal Products for Human Use (CHMP).
“CAR-T cells transform the fight against serious and often fatal diseases in the EU,” commented Martina Schüssler-Lenz, chair of the Committee for Advanced Therapies (CAT). “Kymriah and Yescarta offer an innovative approach where patients’ cells are reprogrammed and reinjected to attack the cancer.”
As Kymriah and Yescarta are advanced-therapy medicinal products, they were assessed by the CAT, which adopts an advisory opinion, and the CHMP. In order to ameliorate the risk of cytokine release syndrome (CRS) from Kymriah and Yescarta, which can be treated with RoActemra (tocilizumab), the CHMP recommended adding the treatment of CAR-T cell induced CRS as an indication for this medicine. Another measure to manage long-term risk will be implanting a patient registry to monitor safety and efficacy.
The European Commission will now receive these recommendations. Once marketing authorizations have been granted, each Member State of the European Union will have the opportunity to set price and reimbursement procedures as appropriate for their individual national health systems.