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新适应证FDA批准Abraxane晚期胰腺癌新适应证美国FDA批准塞尔基因的Abraxane(白蛋白结合紫杉醇纳米粒注射混悬液)新适应证,用于治疗晚期(转移性)胰腺癌。此前,Abraxane还被批准用于治疗乳腺癌(2005年)和非小细胞肺癌(2012年)。FDA是在优先审评程序下完成Abraxane审评的,此外,因胰腺癌是一种罕见的疾病,同时该药也被授予孤儿药资格。Abraxane用于治疗胰腺癌的安全性和有效性基于一项有861名患者参与的临床试验,试验中患
New Indications FDA Approves New Abraxane Advanced Pancreatic Cancer Indications The FDA approved a new indication for Serra Abraxane (albumin-bound paclitaxel nanoparticle injection suspension) for the treatment of advanced (metastatic) pancreatic cancer. Previously, Abraxane was also approved for the treatment of breast cancer (2005) and non-small cell lung cancer (2012). The FDA completed the Abraxane review under the priority review process. In addition, pancreatic cancer is a rare disease and the drug is orphan drug eligibility. Abraxane for the Safety and Efficacy of Pancreatic Cancer is Based on a Clinical Trial Involving 861 Patients in Trial