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 that Ministry of Health, Labour and Welfare has granted marketing approval for antineoplastic drug/bispecific antibody product
BLINCYTO^® Drip Infusion 35μg (generic name: blinatumomab (Genetical Recombination)) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

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.

“Today’s approval of BLINCYTO marks a significant milestone that reinforces our commitment to addressing unmet medical needs of patients and physicians in Japan,” said Steve Sugino, president and representative director of Amgen Astellas. “As our first oncology treatment approved in Japan, we are proud to provide a much needed innovative treatment option for adults and children with relapsed or refractory B-cell ALL, one of the most aggressive B-cell malignancies.”

Hitoshi Kiyoi, M.D., Ph.D., professor of internal medicine, hematology and oncology, Nagoya University Graduate School of Medicine said, “The standard therapy for relapsed or refractory B-cell ALL has not been established in Japan and therefore different chemotherapy regimens have been selected, depending on the condition and background of each patient. BLINCYTO is a much needed and important new treatment option for patients with relapsed or refractory B-cell ALL, as demonstrated by the efficacy and survival benefit seen in the TOWER Study and it may enable effective bridging to allogenic hematopoietic stem cell transplant.”

The approval is based on data from multiple global studies, including the Phase 3 TOWER study and Japan Phase 1b/2 Horai study. In the TOWER study, BLINCYTO demonstrated a superior improvement in median overall survival (OS) versus standard of care (SOC) chemotherapy. Median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO versus 4.0 months (95 percent CI: 2.9, 5.3) for SOC (HR for death=0.71; p=0.012). Safety results among subjects who received BLINCYTO were comparable to those seen in the previous Phase 2 studies of BLINCYTO in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. In the TOWER study, major adverse reactions were pyrexia (39.0 percent), decrease in neutrophil count (14.6 percent), cytokine release syndrome (13.5 percent), febrile neutropenia (10.9 percent), headache (10.1 percent), elevated liver enzyme (10.1 percent) and decrease in platelet count (10.1 percent). In the Phase 1b/2 Horai study, BLINCYTO was administered to 35 Japanese adult and pediatric patients with relapsed or refractory B-cell precursor ALL. The safety results from the Horai study were comparable to those seen in the global studies, including TOWER. In the Horai study, major adverse reactions in adult patients were cytokine release syndrome (46.2 percent), pyrexia (46.2 percent), decrease in neutrophil count (38.5 percent) and decrease in platelet count (34.6 percent), and major adverse reactions in pediatric patients were elevated liver enzyme (66.7 percent), pyrexia (66.7 percent), cytokine release syndrome (55.6 percent) and abdominal pain (44.4 percent).

“As proof-of-concept for our unique bispecific T-cell engager technology, BLINCYTO has laid the groundwork for Amgen to deliver on our passion of addressing cancer by exploring numerous biologic pathways and therapeutic modalities,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This innovation is a good example of how we provide new options and hope to patients with serious illnesses like cancer. In bringing BLINCYTO to Japanese patients, we reinforce our commitment to deliver novel cancer therapies on behalf of patients worldwide.”

BLINCYTO is now approved in 57 countries, including the United States (U.S.), all member countries in the European Union (EU), and the European Economic Area, Canada and Australia.