2010年11月15日,美国食品药品管理局(FDA)宣布,Halaven(甲磺酸艾日布林)已获准用于治疗曾接受至少2种以前的晚期化疗方案治疗的转移性乳腺癌患者。 Halaven是一种从黑色软海绵(Halichondria okadai)中提取的一种有化疗活性化合物的合成制剂。该注射药是一种微管抑制剂,能抑制癌细胞生长。在接受Halaven治疗之前,患者应先接受以前的以蒽环类为基础和以紫杉烷为基础的化疗方案治疗早期或晚期乳腺癌。 Halaven的安全性与疗效在一项涉及762例转移性乳腺癌女性患者的单项研究中得到证实,这些患者曾采用至少2种以前的化疗方案治疗晚期疾病,她们被随机分配至接受Halaven治疗组或接受由其肿瘤医生选择的不同种单药治疗组。 该研究旨在测定总生存时间。Halaven治疗组的中位总生存时间为13.1个月,而单药治疗组为10.6个月。使用Halaven最常见的不良反应包括中性粒细胞减少症、贫血、白细胞减少症、脱发、疲乏、恶心、无力、便秘和周围神经病变。 Halaven approved for late-stage breast cancer The FDA has approved Halaven (eribulin mesylate, from Eisai) for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. This approval was based on a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. The study measured the length of time from when treatment was started until a patient\'s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy. Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer. 美国食品药物管理局已批准Halaven(eribulin甲磺酸,从卫材)为转移性乳腺癌患者谁已经收到了晚期疾病的至少两个前化疗方案治疗。这个批准是基于对762转移性乳腺癌的妇女谁收到了晚期疾病的至少两个疗程化疗前单一的研究。本研究测量的时间从一个时治疗,直到病人死亡(整体存活率)开始的长度。中位数接受Halaven患者的总生存期为13.1个月比10.6对于那些谁收到了单药治疗个月。 |
乳腺癌新型化疗药-Halaven(甲磺酸艾日布林注射剂)获准在美上市简介: 2010年11月15日,美国食品药品管理局(FDA)宣布,Halaven(甲磺酸艾日布林)已获准用于治疗曾接受至少2种以前的晚期化疗方案治疗的转移性乳腺癌患者。
Halaven是一种从黑色软海绵(Halichondria okadai)中 ... 责任编辑:admin |
最新文章更多推荐文章更多热点文章更多 |