Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the launch of antineoplastic drug / bispecific antibody product BLINCYTO® Drip Infusion 35 μg (generic name: blinatumomab (Genetical Recombination)) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) today.

BLINCYTO is the first-and-only bispecific T cell engager (BiTE®) immunotherapy construct approved globally. It is also the first approved immunotherapy from Amgen's BiTE® platform, an innovative approach that helps the body's immune system target cancer cells. 

Yukio Kobayashi, M.D., Ph.D, professor of hematology, International University of Health and Welfare Mita Hospital said, “With advances in medicine to date, about 80 percent of patients with ALL have achieved complete remission after a first-line treatment, however, the estimated 5-year disease-free survival rate remains approximately 50 percent.1 In this way, treatment of relapsed or refractory ALL has room for improvement. I believe that the impact of adding BLYNCYTO, a new immunotherapeutic agent into the options is large.”

Yasushi Yamazaki, Oncology Business Unit Head at Amgen Astellas, said, “We are very delighted to bring a new therapeutic option to Japanese ALL patients who, up to now, had been fighting against the intractable illness with limited choices outside chemotherapy. We remain committed to delivering new innovative therapy to Japanese patients with serious illnesses like cancer.”

Nobuaki Tanaka, Senior Vice President, Sales & Marketing Japan of Astellas said, “We expect the launch of BLINCYTO as the first-and-only bispecific BiTE® immunotherapy construct approved globally will contribute unmet medical needs of ALL patients in Japan.”

BLINCYTO will be jointly promoted by Amgen Astellas and Astellas.