新型双特异性抗体药物BLINCYTO(Blinatumomab)是全球首个也是唯一的双特异性T细胞CD3结合CD19靶向（BiTE）的免疫疗法
BiTE免疫疗法Blincyto（blinatumomab）获美国及欧盟批准上市，用于费城染色体阴性（Ph-）复发性或难治性前体B细胞急性淋巴细胞白血病（ALL）成人患者的治疗。此次批准，使Blincyto成为首个双特异性T细胞衔接器（BiTE）抗体药物
Blincyto（blinatumomab）是全球首个BiTE免疫疗法，基于安进最先进的双特异性T细胞衔接系统（BiTE）开发，这是一种双特异性抗体，能够通过将肿瘤细胞上的CD19蛋白呈递给T细胞特异表达的CD3蛋白，进而激活免疫系统识别并杀灭肿瘤细胞。
BiTE抗体技术代表了一种创新的免疫治疗方法，能够在很低浓度下起作用。目前，安进正在广泛的难治性肿瘤类型中，探索BiTE创新疗法的潜力。此前，FDA和EMA均已授予blinatumomab治疗多种类型血液癌症的孤儿药地位及突破性疗法认定，包括急性淋巴细胞白血病（ALL）、慢性淋巴细胞白血病（CLL）、毛细胞白血病（HCL）、幼淋巴细胞白血病（PLL）和惰性B细胞淋巴瘤、套细胞白血病（MCL）。
批准日期：2014年12月3日[美国]  2015年11月26日[欧盟]   公司：Amgen Inc
BLINCYTO（blinatumomab）注射   为静脉内使用
美国最初批准：2014年
作用机制
Blinatumomab是双特异性CD19指导的CD3 T细胞结合剂，其结合在B谱系起源细胞表面上表达的CD19和在T细胞表面上表达的CD3。它通过将T细胞受体（TCR）复合物中的CD3与CD19在良性和恶性B细胞上连接来激活内源性T细胞。Blinatumomab介导T细胞和肿瘤细胞之间的突触的形成，细胞粘附分子的上调，细胞溶解蛋白的产生，炎症细胞因子的释放和T细胞的增殖，其导致CD19+细胞的重定向裂解。
适应症和用法
BLINCYTO是双特异性CD19定向CD3 T细胞扣合片表示为费城染色体阴性复发或难治的B细胞的前体急性淋巴细胞白血病（ALL）的治疗。这个指示下，加速审批核准。继续批准该适应症可能会在随后的试验验证的临床获益队伍。
用法用量
- 住院推荐的前9天的第一个周期的和的第2天的第二次循环的。
- 治疗的单个循环由4周的连续静脉输注之后是2周无治疗间隔期。
- 对于患者至少45公斤重，在周期1，管理BLINCYTO9微克/天的第1-7天，并在在8-28天28微克/天。对于后续周期，管理BLINCYTO在28微克/天的日子1-28。
•管理
-  Premedicate地塞米松20mg的静脉内前1小时，以每个周期BLINCYTO的首次剂量之前，步骤剂量（如第1个周期第8天），或4小时或更长时间中断后重新开始的输注时。
- 管理作为连续静脉内输注用输液泵以恒定流速。
- 该输液袋应注入超过24小时或48小时。
-  BLINCYTO应通过专用的腔注入。
•准备
- 四解稳定剂被提供并且被用于涂覆预充液IV袋之前加入复溶BLINCYTO的。
- 重新构建BLINCYTO用注射用无菌水，USP，只。
- 当准备输液的解决方案，因为BLINCYTO不含抗菌防腐剂无菌技术要严格遵守。
- 使用掺混说明中描述的特定卷。
剂型和规格
•对于注射：在单次使用的小瓶用于重建35微克冻干粉末。
禁忌
•已知过敏blinatumomab或产品配方的任何成分。
警告和注意事项
•感染：监控病人的体征或症状和治疗适当。
•效果上的驾驶能力和使用机器：建议患者自驾车和从事危险职业或活动，如操作重型或有潜在危险的机器，而BLINCYTO被给予克制。
•编制和管理的错误：严格遵循说明准备（包括掺混）和管理。
不良反应
•最常见的不良反应（≥20％）为发热，头痛，血管神经性水肿，发热性中性粒细胞减少，恶心，低钾血症，震颤，皮疹，便秘等。
Phase 3 Study of BLINCYTO® (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Amgen today announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO® (blinatumomab) versus standard of care (SOC) in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy.
The BLINCYTO adverse events observed in the TOWER study were consistent with the known safety profile of BLINCYTO. Secondary endpoints are currently being evaluated. These interim data will be submitted to a future medical conference and for publication.
"The FDA's breakthrough therapy designation and accelerated approval of BLINCYTO underscore the dire prognosis for these patients. This is the first study to demonstrate an overall survival benefit for these patients with an immunotherapy, and this is a tremendously rare achievement in relapsed and refractory ALL," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We will work with regulatory authorities towards a full approval for BLINCYTO in this population."
About TOWER Study
The TOWER study was a Phase 3, randomized, open-label study investigating the efficacy of the BiTE® antibody BLINCYTO versus SOC chemotherapy in adult subjects with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. Patients were randomized in a 2:1 ratio to receive BLINCYTO or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens. The primary endpoint was OS. Click here to read about the trial on ClinicalTrials.gov.
About ALL                                  
ALL is an aggressive cancer of the blood and bone marrow, the spongy tissue inside bones where blood cells are made. The disease progresses rapidly and affects immature blood cells. Patients with ALL have abnormal white blood cells (lymphocytes) that crowd out healthy white blood cells, red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and other serious side effects.
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
BiTE® antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
About BiTE® Technology
Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
1）：http://www.medicines.org.uk/emc/medicine/31231
2）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa
-------------------------------------------------
产地国家： 德国
原产地英文商品名:
BLINCYTO Injection 38.5mcg/vial 
原产地英文药品名:
Blinatumomab 
中文参考商品译名:
BLINCYTO注射剂 38.5微克/瓶
中文参考药品译名:
双特异性抗体
生产厂家中文参考译名:
安进公司 
生产厂家英文名:
Amgen, Inc 

-------------------------------------------------
产地国家：美国
原产地英文商品名:
BLINCYTO injection 35mcg/vial
原产地英文药品名:
Blinatumomab
中文参考商品译名:
BLINCYTO注射剂 35微克/瓶
中文参考药品译名:
双特异性抗体
生产厂家中文参考译名:
安进公司
生产厂家英文名:
Amgen