乳腺癌新药Ixempra（伊沙匹隆）积极筹备在中国上市申请
关键词： 埃坡霉素 , 抗肿瘤药物 , 微管稳定剂
2007年10月16日，美国大型制药企业之一施贵宝公司宣布其乳腺癌治疗新药Ixempra（化学药，通用名为Ixabepilone）获得FDA批准在美上市，适应症为对其他化疗药物，包括罗氏Roche的Xeloda和赛诺菲-安万特的Taxotere无效的进行期或转移的乳腺癌患者。Ixempra可单独使用，也可以与Xeloda伍用。临床研究证实，Ixempra与Xeloda伍用患者的肿瘤缩小或不增长的平均时间为5.8个月，而单独使用Xeloda的患者仅为4.2个月。Ixempra的费用为每人每年1.84万美元至2.30万美元。预计到2012年，Ixempra的全球销售额将达到5亿美元。目前，乳腺癌新药Ixempra（伊沙匹隆）正积极筹备在中国上市申请，如得到批准，预计在一年左右时间内将在中国上市，为中国晚期乳腺癌患者带来新的治疗选择。
Ixempra：是一种类似紫杉醇微管蛋白聚合和抑制微管解聚活性的埃坡霉素(epothilones)类抗肿瘤新药。FDA批准Ixempra单药用于治疗蒽环糖苷类抗生素、紫杉烷衍生物和卡培他滨治疗无效的转移性或局部进展的晚期乳腺癌；与卡培他滨联用用于治疗蒽环糖苷类抗生素和紫杉烷衍生物治疗无效的转移性或局部进展的晚期乳腺癌。
埃坡霉素(epothilones)：是一类十六元环的大环内酯类药物，最早由Holfe和Reichenbach两人在1992年从粘细菌Sorangium cellulosum种中分离得到，Ixabepilone（BMS-247550）是由Bristol-Myers Squibb（百时美施贵宝，BMS）公司开发的半合成epothilone B内酰胺类似物，属于新一代抗有丝分裂药物，其作用机制与紫杉醇类药物（taxanes）类似，可与微管蛋白结合导致癌细胞无法顺利进行有丝分裂，进而使癌细胞产生凋亡，在抗肿瘤谱、抗肿瘤活性、安全性、水溶性及合成方法等方面均优于紫杉醇，有望发展成为比紫杉醇更有效的抗肿瘤药物。
FDA Approves IXEMPRA™ (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
PRINCETON, N.J., Oct. 16 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of IXEMPRA™ (ixabepilone) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. The FDA has also granted approval of IXEMPRA in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline, and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. IXEMPRA is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones. Bristol-Myers Squibb anticipates that IXEMPRA will be available within days.
"Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options," said Linda Vahdat, M.D., Associate Professor of Clinical Medicine and Associate Attending Physician, New York-Presbyterian Hospital/Weill Cornell Medical Center. "The approval of IXEMPRA means that we now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies."
"Bristol-Myers Squibb has a rich history in oncology spanning more than 40 years, and we are extremely proud that IXEMPRA has been approved as it is a significant addition to the Bristol-Myers Squibb oncology portfolio and addresses a serious unmet medical need in the treatment of patients with metastatic or locally advanced breast cancer," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chie Scientific Officer and President, Research and Development, Bristol-Myers Squibb.
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