EMA推荐依维莫司用于乳腺癌治疗

欧洲药品管理局(EMA)6月22日宣布推荐抗癌药物依维莫司(Afinitor，诺华)扩大适应证范围，用于激素阳性、HER2阴性晚期乳腺癌患者治疗。依维莫司此前已被EMA推荐用于治疗胰腺癌和肾细胞癌，此次依维莫司联合依西美坦被推荐用于芳香化酶抑制剂治疗失败的绝经后女性患者的二线治疗。

EMA还扩大了依那西普和阿达木单抗治疗两种风湿病的适应证范围。依那西普(恩利，辉瑞)在欧洲已获准用于治疗成人类类风湿性关节炎，此次EMA推荐将其用于不宜接受甲氨蝶呤治疗或治疗失败的儿童和青少年多关节型(类风湿因子阳性或阴性)、扩展性少关节型和银屑病性关节炎患者。此外，适应证还扩至常规治疗无应答的与附着点炎症相关的≥12岁青少年关节炎。阿达木单抗(Humira，雅培)在欧洲已被批准用于多种风湿性疾病治疗，此次被推荐用于对非甾体抗炎药物应答不足或不能耐受的严重中轴性脊柱炎成人患者。新适应证包括缺乏中轴性脊柱炎放射影像学证据但具有MRI检查炎症证据或C-反应蛋白升高的患者。

在6月份会议上，EMA还推荐赛诺菲巴斯德的一种新的6合1联合疫苗Hexaxim用于6岁儿童白喉、破伤风、百日咳、乙型肝炎、脊髓灰质炎以及包括脑膜炎等嗜血杆菌所致疾病的预防接种。该疫苗需接种3剂，间隔时间≥4 w，已在欧盟以外国家上市。EMA称，Hexaxim疫苗中的5种活性成分此前已被用于其他疫苗，并已联合作为赛诺菲巴斯德生产的Pentaxim疫苗的成分。新疫苗添加了汉逊酵母表达的重组乙型肝炎表面抗原，在阿根廷、墨西哥、秘鲁、土耳其、泰国和南非进行的临床试验表明，新疫苗与Pentaxim+单价乙肝疫苗同样有效和安全。

EMA还推荐了3种新药：

•替度鲁肽(Revestive，奈科明)，皮下注射剂，用于治疗因严重肠部疾病或小肠大部切除导致营养成分不能吸收的短肠综合征。

•格隆溴铵(Enurev，诺华)，支气管扩张维持药物，用于缓解成人慢性阻塞性肺病症状。

•头孢洛林酯(Zinforo，阿斯利康)，输液剂，用于成人复杂性皮肤和软组织感染以及社区获得性肺炎。

EMA还宣布，基于安全性考虑，限制两种药物的适应证。在收到德国有关超敏反应的报告后，该机构建议医生对卒中后痉挛之外的适应证不再开具托哌酮，并以口服制剂代替注射剂。托哌酮是一种肌肉松弛剂，自上世纪60年代开始在欧洲应用，目前仅少数国家仍在使用。EMA在法国报告应用曲美他嗪与帕金森症状、不宁腿综合征、震颤和步态不稳等运动障碍有关后，建议限制该药物用于二线、添加治疗。含有曲美他嗪的药物自上世纪70年代开始在欧洲被用于治疗心绞痛。EMA还建议医生不要对具有上述症状以及相关运动障碍的患者或严重神功能损害患者开具此药。

EMA的推荐最终都需得到欧盟委员会批准才能生效。

爱思唯尔  版权所有

BY JENNIE SMITH
Elsevier Global Medical News
Breaking News

The European Medicines Agency said June 22 that it had recommended an extension of indication for the cancer drug everolimus to treat hormone receptor–positive, HER2–negative advanced breast cancer.

Everolimus (Afinitor, Novartis), already recommended by the EMA to treat pancreatic and renal cell cancers, is now recommended throughout the European Union in combination with exemestane as a second-line treatment in postmenopausal women in whom aromatase inhibitors have failed.

EMA also extended indications of agents used to treat two rheumatic diseases.

Etanercept (Enbrel), marketed by Pfizer and already licensed in Europe to treat rheumatic arthritis in adults, is now recommended as a treatment for polyarthritis (rheumatoid factor positive or negative), extended oligoarthritis, and psoriatic arthritis in children and adolescents in whom methotrexate has failed or is inappropriate. The indication for etanercept also was extended to treatment of enthesitis-related arthritis in adolescents 12 years and older not responding to conventional therapy.

Adalimumab (Humira), marketed by Abbott and licensed in Europe to treat a range of rheumatic diseases, will now be indicated for the treatment of adults with severe axial spondyloarthritis who have had an inadequate response to, or are intolerant of, nonsteroidal anti-inflammatory drugs. The new indication covers patients without radiographic evidence of axial spondyloarthritis but with evidence of inflammation determined by MRI or elevated C-reactive protein.

Also at its June meeting, the agency recommended a new six-in-one combination vaccine developed for use outside the European Union. Hexaxim, marketed by Sanofi Pasteur, will be used in children aged 6 weeks to 2 years old to inoculate against diphtheria, tetanus, pertussis, hepatitis B, polio, and diseases caused by Haemophilus influenzae type B, including meningitis. The vaccine is administered as three doses 4 or more weeks apart.

Five of the active substances in the vaccine have been used in other vaccines and have been previously combined in Pentaxim, also manufactured by Sanofi Pasteur. The new vaccine adds Hansenula polymorpha-derived recombinant hepatitis B surface antigen. Clinical trials in Argentina, Mexico, Peru, Turkey, Thailand, and South Africa found the new vaccine to be as effective and safe as Pentaxim plus a monovalent hepatitis B vaccine, EMA said.

EMA recommended three additional new medications:

• Teduglutide (Revestive, Nycomed), a subcutaneous injection to treat short-bowel syndrome, a condition in which nutrients are not absorbed as a result of severe intestinal disease or the surgical removal of a large portion of the small intestine.

• Glycopyrronium bromide (Enurev, Novartis), a maintenance bronchodilator treatment for symptom relief in adults with chronic obstructive pulmonary disease.

• Ceftaroline fosamil (Zinforo, AstraZeneca), an infusion for treatment of adults with complicated skin and soft-tissue infections and community-acquired pneumonia.

The agency also announced that it was restricting indications for two medications on safety concerns. Following reports from Germany of hypersensitivity reactions, the agency advised clinicians not to prescribe tolperisone for indications other than poststroke spasticity and to use oral formulations in place of injectable ones. Tolperisone is a muscle relaxant used in Europe since the 1960s and only available in a handful of countries.

EMA recommended restricting the use of trimetazidine to second-line, add-on therapy after reports from France of movement disorders including Parkinsonian symptoms, restless leg syndrome, tremors and gait instability associated with the medicine. Trimetazidine-containing medicines have been available since the 1970s in Europe and are used in the treatment of patients with angina pectoris. Clinicians are also advised not to prescribe in patients with these and related movement disorders, or those who have severe renal impairment.

All EMA recommendations require European Commission approval to be final.