30 March 2020 - Submission based on previous pivotal trial data and a phase 2 study in Japan in patients with certain relapsed/refractory B-cell lymphomas.
Daiichi Sankyo today announced that it has submitted a new drug application to Japan’s Ministry of Health, Labour and Welfare for chimeric antigen receptor T cell therapy axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma and related lymphomas.
In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialisation rights for axicabtagene ciloleucel in Japan from California-based Kite, a Gilead Company.