产地国家：法国

处方药：是

所属类别： 4毫克/毫升/瓶

包装规格： 4毫克/毫升/瓶

计价单位：瓶

生产厂家英文名：IDM Pharma S.A.

原产地英文商品名：Mepact powder infusion 4mg/vial

原产地英文药品名：mifamurtide

中文参考商品译名：Mepact粉末懸浮液 4毫克/毫升/瓶

中文参考药品译名：米伐木肽

简介：

骨肉瘤最新治疗药—米伐木肽在欧上市米伐木肽通过刺激诸如巨噬细胞等某些白细胞来杀灭肿瘤细胞，是20余年来首个获准上市治疗骨肉瘤的新药，研究显示，米伐木肽与化学药物联合使用可使死亡率降低约30%，78%经治疗的患者存活长达6年以上。欧洲批准IDMPharma公司的米伐木肽注射剂（mifamurtide，L-MTP-PE，:Mepact）上市，用于治疗非转移性可切除的骨肉瘤（少见但主要造成儿童和青年死亡的骨瘤）。

本品是20余年来首个获准上市治疗骨肉瘤的新药。米伐木肽是20余年来首个改善骨肉瘤患者长期存活的药品。患者术前化疗，随后手术切除骨瘤，而后再化疗。当患者接受术后化疗的同时也静脉注射注射米伐木肽进行免疫治疗（一周2次，3个月，随后一周1次，6个月）。

研究显示，米伐木肽可彻底清除疾病显微战壕内的残留物。米伐木肽通过刺激诸如巨噬细胞等某些白细胞来杀灭肿瘤细胞。本品制成球形脂质体，囊泡内是胞壁酰三肽（MTP）。此脂质触发巨噬细胞去消耗米伐木肽。一旦消耗完，MTP刺激尤其是在肝、脾和肺内的巨噬细胞去寻找肿瘤并杀灭之。米伐木肽注射剂获准上市基于Ⅲ期临床研究结果。国立癌症研究所（NCI）建立的协作组，由儿童肿瘤组（COG）进行研究，完成本品治疗骨肉瘤最大研究课题在册的患者约800例。研究评价了米伐木肽与3～4种辅助化疗药（顺铂、多柔比星、甲氨蝶呤、有或无异环磷酰胺）联合用药的结果。研究显示，米伐木肽与化学药物联合使用可使死亡率降低约30%，78%经治疗的患者存活长达6年以上。

英文版说明书：

Mechanism Identified That Increases Effectiveness of Therapy Against LeukemiaIn a recent issue of the medical journal BLOOD, researchers from the Children’s Cancer Hospital at M. D. Anderson reported that combining two specific drugs appears to be five times more effective against leukemia than either cancer agent alone.For the first time, associate professor of pediatrics Joya Chandra, Ph.D., and graduate student Claudia Miller showed that the novel proteasome inhibitor, NPI-0052, shares similar functions as the histone deacetylase (HDAC) inhibitor, vorinostat.“Combining the two anti-cancer agents should allow clinicians to use a lower dosage of each drug, which hopefully will result in fewer side effects for the patient,” says Chandra. “For pediatric patients in particular, the fewer side effects they have from treatment could mean a better quality of life as survivors in the long run.”NPI-0052 is currently being tested with solid tumor malignancies and recurrent lymphoma in Phase I human clinical trials at M. D. Anderson. A combination trial to test NPI-0052 with vorinostat is in the planning.Device Aims to Decrease Wait Period for Patients Needing ImmunotherapyPaul (Yoonsu) Choi, Ph.D., from the Children’s Cancer Hospital at M. D. Anderson has created a device, called HitMeD (high throughput medical electroporation device), that significantly decreases the time needed to produce genetically manipulated T cells in preclinical tests for leukemia.Multiple relapsed acute lymphocytic leukemia (ALL) in pediatric patients is a rapidly progressive cancer that is often resistant to chemotherapy, leading to poor survival prognosis. Since chemotherapy typically fails these patients, new approaches, such as cell-based therapy, are needed to combat the quickly spreading leukemia.Choi, along with senior researcher Laurence Cooper, M.D., Ph.D., from the Children’s Cancer Hospital, are studying ways to genetically manipulate T cells, an important component of a person’s immune system, to specifically attack tumor cells while keeping risk to the patient at a minimum.Cooper and researchers are planning a Phase I trial that could open this year. This trial would allow multiple-relapsed ALL patients to receive manipulated T cells that have been processed by HitMeD. These special T cells will act like an army of antibodies rushing in to attack tumor cells, but quickly retreating after their ammunition is used. With HitMeD, doctors hope to infuse additional doses of T cells more rapidly to sustain the fight until the patient can receive additional treatment, such as a stem cell transplant.Immune-Based Drug Approved in Europe for Pediatric Bone Cancer PatientsThe European Commission, which oversees legislation and regulation for the European Union, has approved a therapy for pediatric patients with non-metastatic, resectable osteosarcoma, a type of bone cancer. The approval is based on clinical studies led by researchers at the Children's Cancer Hospital at M. D. Anderson and a national co-operative group.MEPACT (mifamurtide, L-MTP-PE) is an immune-based therapy, that when combined with chemotherapy, resulted in approximately a 30% decrease in the risk of death with 78% of patients surviving more than six years following treatment. This therapy is the first in more than 20 years to improve the long-term survival of osteosarcoma patients.Patients receiving MEPACT in Europe will undergo pre-operative chemotherapy followed by surgery to resect the bone tumor and then receive post-operative chemotherapy. While receiving post-operative chemotherapy, patients will also be given the immune therapy intravenously twice a week for three months and then once a week for six months. The chemotherapy acts like a bomb sent in to destroy the tumor, while MEPACT acts as a special forces unit sent in to clean out any remaining pockets of microscopic disease.“Relapsed osteosarcoma is often resistant to chemotherapy,” says Eugenie Kleinerman, M.D., head of the Children's Cancer Hospital and lead researcher for MEPACT. “By giving MEPACT to newly diagnosed patients, we hope to prevent relapse by taking care of any remaining tumor cells after chemotherapy.”Currently, only relapsed pediatric patients with osteosarcoma are able to receive treatment with MEPACT through compassionate use in the United States.