Empliciti(elotuzumab 中文药名：埃罗妥珠单抗)为一种新免疫刺激治疗新药，获美国FDA批准治疗多发性骨髓瘤 2015年11月30日美国食品和药品监管局(FDA)授权批准Empliciti (埃罗妥珠单抗[elotuzumab])与两个其他治疗联用治疗有多发性骨髓瘤曾接受一至三次以前药物的人们。 多发性骨髓瘤是血癌的一种形式发生在感染斗争浆细胞(白细胞的一种类型)在骨髓发现。这些癌细胞倍增，产生一种异常蛋白和将其他健康血细胞从骨髓推出。这个疾病可能导致一个变弱的免疫系统，和致其他骨和肾问题。美国国家癌症研究所估计美国今年在将有26,850多发性骨髓瘤新病例和11,240例相关死亡。 FDA的药品评价和研究中心中血液学和肿瘤室主任Richard Pazdur，M.D.说：“我们正在继续学习关于与不同类型癌，包括多发性骨髓瘤免疫系统相互作用途径，”“今天的批准是第二个被批准治疗有多发性骨髓瘤患者的第二个单克隆抗体和作用与另外被批准的治疗提供另外获益。” 在这个月较早批准Darzalex (daratumumab)，是唯一的其他FDA-批准的为有多发性骨髓瘤患者的治疗单抗。 Empliciti活化机体的免疫系统攻击和杀死多发性骨髓瘤细胞。它被批准与另一个与另一个FDA-批准为多发性骨髓瘤被称为Revlimid(来那度胺[lenalidomide])和地塞米松[dexamethasone] (皮质激素的一类型)的治疗联用。 在646例其多发性骨髓瘤复发后，或对以前治疗不反应参加者一项随机化，开放临床研究中测试Empliciti的安全性和疗效。用Empliciti加Revlimid和地塞米松参加者与只用Revlimid和地塞米松(14.9个月)参加者比较在他们的疾病恶化前经历一个时间量中延迟(19.4个月)。此外，用Empliciti与Revlimid和地塞米松参加者的78.5%见到他们的肿瘤完全或部分皱缩，与之比较只用Revlimid和地塞米松参加者为65.5%。 Empliciti的最常见副作用是疲乏，腹泻，fever (发热)，便秘，咳嗽，神经损伤导致软弱或手和足中麻木(周围神经病变)，鼻和喉的感染(鼻咽炎)，上呼吸道感染，食欲减退和肺炎。 FDA对这个申请授予突破性治疗指定，它是授予当一个药物一项治疗一种严重情况和初步临床证据表明该药物可能在一个或多个临床上意义终点显示实质上改进超过可得到治疗。 Empliciti还接受优先审评和孤儿药物指定. 优先审评状态是授予申请对药物，如被批准在一个严重情况的治疗在安全性和有效性将被显著改进。孤儿药物指定提供鼓励例如税收减免，用户费用减免和对孤儿药物专有权资格有助和鼓励对罕见疾病药物开发。 Empliciti是由纽约州纽约Bristol-Myers Squibb上市。Darzalex的宾州Horsham的Janssen Biotech上市。Revlimid由总部新泽西Summit Celgene 公司上市 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm Empliciti (elotuzumab)Indication New Drugs Online Report for elotuzumab Information Generic Name: elotuzumab   Trade Name: Empliciti  Synonym: BMS-901608 , HuLuc63  Entry Type: New molecular entity   Development and Regulatory status UK: Pre-registration (Filed)  EU: Pre-registration (Filed)  US: Approved (Licensed)  UK launch Plans: Available only to registered users Actual UK launch date:   Comments Nov 15: Approved in the US to treat multiple myeloma in combination with lenalidomide and the dexamethasone, in patients who have already received at least one prior treatment [12]. 01/12/2015 10:03:07  Sep 15: Filed in US. FDA has agreed to a six-month review of its marketing application. The filing is based in part on early data from the 646-patient ELOQUENT-2 trial [11]. 03/09/2015 12:40:07  Jul 15: The EMA validated for review the Marketing Authorization Application (MAA) for elotuzumab for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the CHMP. [10] 28/07/2015 10:14:19  May 14: US FDA designated elotuzumab in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies, breakthrough therapy. [6] 20/05/2014 08:47:02  Oct 12: Orphan designation (EU/3/12/1037) granted in Aug 12 in the EU for the treatment of multiple myeloma. It also has orphan status in the US [2] 03/10/2012 09:25:17  Mar 11: PIII study started [1]. 20/04/2011 10:26:37  Trial or other data Jun 15: Results of ELOQUENT-2 (NCT01239797) published in the NEJM [9]. 04/06/2015 11:37:40 May 15: Early data from the Phase III ELOQUENT-2 trial has demonstrated increased progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma for patients taking elotuzumab with Revlimid (lenalidomide) and dexamethasone . Results taken at two-year follow-up showed that PFS in patients given the elotuzumab-based therapy regimen was 19.4 months compared to 14.9 months in the control arm, while one-year PFS was 68% versus 57%, and two-year PFS 41% vs 27%, respectively [8]. 15/05/2015 12:50:29 Mar 15: ELOQUENT-2 is on-going but not recruiting patients. Dates given: Primary outcome data - May 16 and Completion Mar 18 [7]. 29/03/2015 17:07:02 Apr 14: NCT01239797 (ELOQUENT-2) - August 2017 is anticipated date for final data collection date for primary outcome measure [5]  28/04/2014 15:36:39 June 13: Updated efficacy and safety data from a small, randomised Phase II, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone. In the 10 mg/kg arm (N=36), median progression-free survival (PFS) was 33 months after a median follow-up of 20.8 months (95% CI: 14.9-NA) and the objective response rate (ORR) was 92%. The most common Grade 3/4 adverse events (seen in > 5% of patients) for the 10 mg/kg and 20 mg/kg arms respectively were lymphopenia (26% and 9%), neutropenia (21% and 22%), thrombocytopenia (21% and 17%), anemia (13% and 12%), leukopenia (8% and 7%), hyperglycemia (5% and 12%), pneumonia (8% and 5%), diarrhea (10% and 5 %), fatigue (8% and 9%), and hypokalemia (8% and 5%). Two deaths occurred on study (multiple adverse events [n=1; pneumonia, multiple organ failure and sepsis]). [4]  18/06/2013 10:47:22 Dec 12: Results from small PII open-label study in 36 pts; two doses of elotuzumab (10mg/kg and 20mg/kg) in combination with lenalidomide and low dose dexamethasone. In the 10 mg/kg arm, median progression-free survival (PFS), or the time without disease progression or death, was not reached after 20.8 months of follow up (N=36) and the objective response rate (ORR) was 92%. In the elotuzumab 20 mg/kg arm, median PFS was 18.6 months (N=37) and ORR was 76%. [3] 11/12/2012 09:24:53 Mar 11: NCT01239797 is a PIII, randomized, open label trial of lenalidomide/dexamethasone with or without elotuzumab in 640 patients with relapsed or refractory multiple myeloma. The primary endpoint is progression free survival. The study started in Mar 11 and is due to complete Oct 17 [1]. 20/04/2011 10:27:44 Evidence Based Evaluations NHSC/NIHR  http://www.hsc.nihr.ac.uk/topics/elotuzumab-for-relapsed-or-refractory-multiple-mye/  References   Available only to registered users  Category BNF Category: Drugs affecting the immune response (08.02) Pharmacology: Humanized anti-CS1 monoclonal IgG1 antibody   Epidemiology: The incidence of MM in the UK is about 5 per 100,000 population. Median survival of patients with stage II and III disease is 45 and 29 months, respectively.   Indication: Multiple myeloma (MM)  Additional Details: second-line plus, combination therapy  Method(s) of Administration   Intravenous  Oral  Company Information Name: Bristol-Myers Squibb  US Name: Bristol-Myers Squibb  Further Information Anticipated commissioning route (England) NHSE  High cost drug list? Awaiting Update Implications Available only to registered users