Oxford BioMedica PLC said Japan's Ministry of Health, Labour and Welfare approved Kymriah to treat two forms of blood cancer.
Novartis AG's gene therapy Kymriah, also known as tisagenlecleucel, can now be used in Japan to treat patients with CD19-positive B-cell acute lymphoblastic leukemia and those with CD19-positive diffuse large B-cell lymphoma. Both indications comprise patients whose cancer has returned after previously being in remission or is resistant to treatment.
Kymriah is the first CAR-T therapy approved in Asia for these two B-cell malignancies, Oxford BioMedica said.
Oxford, U.K.-based Oxford BioMedica manufactures lentiviral vectors, which have the ability to deliver genetic information into a cell. These vectors are used in chimeric antigen receptor T-cell, or CAR-T, therapies, which use re-engineered immune cells aimed at fighting cancer cells.
Oxford BioMedica is the sole manufacturer of the lentiviral vectors used in Kymriah, which has received approvals from the European Commission and the U.S. Food and Drug Administration to treat certain types of blood cancer.
Production of Kymriah — the first CAR-T therapy to be approved by U.S. regulators in 2017 and a potential blockbuster drug — will increase fourfold in 2019, Basel, Switzerland-based Novartis said.