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YONDELIS(ET-743 trabectedin injection)使用说明
Yondelis®是一种全新的、多模块合成的抗癌药。该药物通过不同的药物作用机制阻止肿瘤发展，包括捆绑DNA（脱氧核糖核酸）阻止细胞再生、抑制活化转移和蛋白质参与DNA修复、改变肿瘤微环境。
批准日期：2016年7月 公司：强生制药公司
Yondelis（曲贝替 trabectedin）用于注射，用于静脉内使用
美国初始批准：2015年
目前的主要变化
用法与用量07/2016
警告和注意事项07/2016
作用机理
是一种烷基化药物曲贝替结合在DNA的小沟鸟嘌呤残基，形成加合物和在朝向大沟DNA螺旋的弯曲所致。加合物的形成触发事件可以影响DNA的后续活动结合蛋白，治疗包括一些转录因子，和DNA修复途径的级联，在细胞周期和最终的细胞死亡的扰动所致。
适应症和用法
Yondelis是表明治疗晚期或转移性脂肪肉瘤或平滑肌肉瘤的治疗烷基化药物接受含有世卫组织方案事先蒽环类药物
用法用量
在1.5毫克/ m2体表面积辖为24小时静脉滴注，每3周通过中心静脉导管
术前用药：每次输液前20地塞米松静脉毫克30分钟
肝损伤：在0.9毫克/ m2体表面积辖为24小时静脉滴注，每3周通过中心静脉导管在患者与中度肝损伤
剂型和规格
注射：1毫克无菌冻干粉末在单一剂量小瓶
禁忌症
已知过敏贝替
警告和注意事项
中性粒细胞减少败血症：严重和致命的败血症中性粒细胞减少可能会出现。在中性粒细胞计数监测治疗。扣压Yondelis 2级或更大的中性粒细胞减少
横纹肌溶解症：横纹肌溶解症，可能会出现;扣压Yondelis对严重或危及生命的肌酸磷酸激酶水平的提高
肝：肝毒性发生。监控和延迟和/或如果需要减少剂量
心肌病可发生严重和致命性心肌病。 Yondelis在患者与扣住左心功能不全
胚胎 - 胎仔毒性：可引起胎儿造成伤害。潜在风险提醒到胎儿，并使用有效的避孕
不良反应
最常见的（≥20％）的不良反应有恶心，乏力，呕吐，便秘，食欲下降，腹泻，血管神经性水肿，呼吸困难和头痛。最常见（≥5％）3-4级实验室检查异常有：白细胞减少，ALT升高，血小板减少，贫血，增加AST，肌酸磷酸激酶和增加。
药物相互作用
CYP3A酶抑制剂：避免随之而来的强CYP3A酶抑制剂
CYP3A诱导：避免强CYP3A诱导相伴
特殊人群中使用
哺乳期：哺乳期不推荐
不要给予YONDELIS给患者带来严重的肝功能损害
完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=472bd78e-be17-4b9d-90f4-9482c3aec9ff
原研厂家:PharmaMar (Orphan Drug), University of Illinois (Originator), Ortho Biotech (Licensee), PharmaMar (Licensee), Zeltia (Licensee)
作用类别:Breast Cancer Therapy, Lung Cancer Therapy, Non-Small Cell Lung Cancer Therapy, Oncolytic Drugs, Ovarian Cancer Therapy, Prostate Cancer Therapy, Solid Tumors Therapy, Apoptosis Inducers, DNA-Intercalating Drugs
研发状态:Pre-Registered
曲贝替定(Trabectedin，强生制药公司)是首个海洋来源抗肿瘤药，为在海鞘中提取的四氢喹啉类生物碱的半合成品。除了可阻滞肿瘤细胞在G1／G2周期的分化外，还可抑制血管内皮细胞生长因子(VEGF)的分泌及VEGF受体(VEGFR)-1的表达。2004年，其在欧、美已被指定为治疗急性淋巴母细胞白血病、软组织肉瘤和卵巢癌的孤儿药。2007年，EMEA正式批准其用于进展型软组织肉瘤的二线治疗
abectedin (亦称 ecteinascidin 743 或 E-743)是一种anti-tumor药物。 它由Zeltia开发和 强生公司配药研究与开发 并且被卖在品牌之下 Yondelis. 它是批准用于欧洲和南韩为治疗先进 软的组织肉瘤.[1] 它也接受临床试验为乳房、摄护腺和小儿科肉瘤的治疗。[2] 欧共体和美国食物&药物管理授予了 孤儿药物 状态对trabectedin为软的组织肉瘤和卵巢癌。
U.S. FDA Grants Priority Review for YONDELIS® (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma
U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for YONDELIS® (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
Priority Review is a designation for a drug that treats a serious condition and may offer major advances in treatment when compared to existing options. A priority review designation means the FDA's goal is to take action, following the two month period for the validation and acceptance of the NDA, within six months as compared to 10 months under standard review.
The filing is based on the Phase 3 randomized, open-label study ET743-SAR-3007. This trial is eva luating the safety and efficacy of trabectedin versus dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma, the most common types of STS in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.
“We are excited the FDA has granted Priority Review for YONDELIS, as it is an important step forward in making this therapy available to physicians and those living with this aggressive disease,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen.
About Soft Tissue Sarcoma
Soft tissue sarcomas are a type of cancer originating in the soft tissues that connect, support and surround other body structures,[1] such as muscle, fat, blood vessels, nerves, tendons and the lining of joints. In the U.S., nearly 12,000 people will be diagnosed and approximately 4,870 are expected to die of soft tissue sarcomas in 2015.[2] Leiomyosarcoma is an aggressive type of soft tissue sarcoma that occurs in smooth muscles, such as those in the uterus, gastrointestinal tract or lining of blood vessels. [3] Liposarcoma originates in fat cells and most commonly occurs in the thigh and abdominal cavity, though it can occur in fat cells in any part of the body.[4],[5]
About YONDELIS® (trabectedin)
YONDELIS® (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing the tumor cells from multiplying and is approved in 77 countries, within North America, Europe, South America and Asia, for the treatment of advanced soft-tissue sarcomas as a single-agent, and in 70 countries for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection). |
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