ATMP innovation is steadily picking up speed, as evidenced by the approval of many new ATMPs, including the first CAR-T cell products Kymriah and Yescarta, and the first medicine for retinal dystrophy, Luxturna. At European level, a further increase of applications is expected this year. Many of the new developments are for gene therapies, which are finally fulfilling their longstanding promise, with cell-based gene therapies at the forefront of this. Yet, at least in Europe, a number of regulatory challenges remain and new ones are emerging at the same time.
