2015年3月4日讯 /生物谷BIOON/ --生物技术巨头新基（Celgene）明星药物Abraxane（注射用紫杉醇[白蛋白结合型]）近日在欧盟喜获新适应症——非小细胞肺癌（NSCLC）。欧盟委员会（EC）已批准Abraxane联合卡铂（carboplatin）用于不适合潜在可治愈性手术和/或放射治疗的非小细胞肺癌（NSCLC）成人患者的一线治疗。在欧盟，Abraxane已获批的其他适应症还包括：转移性胰腺癌和乳腺癌。
Abraxane是Celgene公司的主力产品，该药是一种化疗药物，因乔布斯之死和癌中之王——胰腺癌适应症而名声大噪。在相关临床试验中，Abraxane针对其他多种癌症也具有强劲疗效，包括黑色素瘤、膀胱癌、卵巢癌以及乳腺癌、肺癌的。自2013年获批胰腺癌之后Abraxane发展势头迅猛，全球销售一路飙升。而凭借与百时美施贵宝（BMS）的合作，Celgene也顺利进入肿瘤免疫治疗市场。双方目前正在多种类型肿瘤中调查肿瘤免疫疗法Opdivo（nivolumab）与Abraxane组合疗法的潜力。
Abraxane非小细胞肺癌（NSCLC）新适应症的获批，是基于一项多中心随机开放标签研究的结果，涉及1052例化疗初治的IIIb/IV非小细胞肺癌(NSCLC)成人患者。研究中，将Abraxane联合卡铂用于晚期NSCLC患者的一线治疗，并与紫杉醇+卡铂组合疗法进行了对比。数据表明，Abraxane+卡铂治疗组总缓解率显著高于紫杉醇+卡铂治疗组（33% vs 25%），达到了研究的主要终点。
肺癌是男性和女性中第四种最常见癌症，在欧洲是癌症相关死亡的主要原因。非小细胞肺癌（NSCLC）是肺癌中最常见的形式，约占所有病例的85-90%。当前的治疗方案通常包括全身化疗或蛋白激酶抑制剂。但针对晚期病情，目前唯一能做的通常只能是控制疾病的症状，因此该领域对创新药物存在着明确的医疗需求。
英文原文：ABRAXANE® Approved by European Commission for First-Line Treatment of Patients with Non-Small Cell Lung Cancer
Nanotechnology Therapy Now Available for Patients in European Union with Lung Cancer
BOUDRY, Switzerland--(BUSINESS WIRE)-- Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Commission (EC) has approved ABRAXANE® (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
The ABRAXANE Marketing Authorisation has been updated across 28 member states in the European Union to include this new indication in non-small cell lung cancer (NSCLC), adding to the existing indications for the treatment of metastatic pancreatic and breast cancers.
Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 to 90% of all cases. The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer.
The EC decision follows the positive CHMP opinion received on 23 January and is based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared ABRAXANE in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. The primary efficacy endpoint, overall response rate, was significantly higher for patients in the ABRAXANE/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions (≥ 20%) of ABRAXANE in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.
Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, "At Celgene, we are pleased that the EC's approval of ABRAXANE in NSCLC allows patients in Europe who have been diagnosed with this devastating disease to access this innovative nanotechnology medicine. The expanded application of ABRAXANE across three difficult to treat tumors - breast, pancreatic and lung cancers - reinforces the value ABRAXANE provides and our commitment to advance transformational science, deliver life-enhancing medicines and serve patients with cancers the world over."
About ABRAXANE® (nab-paclitaxel)
ABRAXANE® is a nanotechnology agent that is currently the only albumin-based nanotechnology therapy approved for the treatment of metastatic breast cancer, non-small cell lung cancer and pancreatic cancer in the United States, Europe and other markets around the world. It contains albumin-bound paclitaxel nanoparticles and is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. In Europe, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. ABRAXANE is now approved in more than 50 countries for the treatment of metastatic breast cancer.
In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand and Singapore.
In September 2013, the FDA approved ABRAXANE as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in Europe. ABRAXANE is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.