The two items approved were

  • Anges Co. HGF gene therapy for treatment of critical limb ischemia (AMG0001, beperminogene perplasmid)
  • Novartis CAR-T cell therapy Kymriah (Tisagenlecleucel) for the treatment of acute lymphoblastic B-cell leukemia

Nikkei Biotech news release, February 21, 2019