Japanese approval of Kymriah makes it the first CAR-T cell therapy authorized in Asia

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).

If all goes well Swiss pharma giant Novartis’ (NOVN: VX) Kymriah could be listed for reimbursement as early as May although there are uncertainties surrounding its pricing.

The approval further expands the global reach of chimeric antigen receptor T cell (CAR-T) therapy Kymriah, a ground-breaking treatment that is developed from a patient's own T cells to fight cancer. 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.