OXFORD, UK: Oxford Biomedica plc, a leading gene and cell therapy group, notes an announcement by Novartis that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kymriah® (tisagenlecleucel) for the treatment of two distinct indications – CD19-positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and CD19-positive r/r diffuse large B-cell lymphoma (DLBCL).
Kymriah is the first and so far only CAR-T therapy to receive regulatory approval in Asia for these two B-cell malignancies. The approval of Kymriah in Japan also follows the successful completion of the technical transfer at the Foundation for Biomedical Research and Innovation (FBRI) at Kobe for the clinical manufacturing of Kymriah.
Kymriah is a living medicinal product, manufactured individually for each patient by reprogramming the patient’s own immune system cells. The approval in Japan follows regulatory authorisations in the United States, Europe including Switzerland, Canada and Australia. The MHLW reviewed data from the global registration CAR-T clinical trials, JULIET and ELIANA, which included investigational sites in Japan. In these trials, Kymriah demonstrated strong and durable response rates and a consistent safety profile in two distinct difficult-to-treat patient populations1.
Oxford Biomedica is the sole manufacturer of the lentiviral vector used in Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products with the potential to generate in excess of USD 100 million in income for OXB over the three years of the contract.