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nintedanib在欧盟(商品名：Vargatef)批准用于肺癌、在美国(商品名:OFEV)批准用于特发性肺纤维化的治疗。
• The approval of nintedanib* in the EU is primarily based on the positive results of the LUME-Lung 1 study of over 1,300 patients in 27 countries1 • In oncology, nintedanib* will be marketed in the European Union under the brand name Vargatef® For media outside UK, US and Canada only Ingelheim, Germany, 27 November 2014 – Today Boehringer Ingelheim announced that the European Commission has granted EU marketing authorisation for Vargatef® (nintedanib*), valid for the 28 countries within the EU. Vargatef® in combination with docetaxel is indicated for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. “The approval of nintedanib offers a much needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting,” commented PD. Dr Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany and lead investigator of the LUME-Lung 1 trial. “The clinical data has shown that patients receiving nintedanib plus docetaxel experienced over one year overall survival with no further compromise to their quality of life, compared to docetaxel alone.” Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage.2 Most patients will experience disease progression during or after first-line chemotherapy and there is a significant unmet need for new, effective second-line treatments.3 “We are delighted by the European Commission’s decision to approve Vargatef® in the EU and feel extremely proud that our long standing commitment to oncology research and development has brought a new option to lung cancer patients with this specific type of disease,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “The approval of Vargatef® expands our oncology portfolio, following last year’s approval of GIOTRIF® (afatinib) for another specific type of lung cancer. In the idiopathic pulmonary fibrosis indication, nintedanib has recently been approved by the U.S. FDA.” The approval of nintedanib*, a triple angiokinase inhibitor, is based on the outcomes of the LUME-Lung 1 clinical trial which enrolled 1,314 patients with NSCLC, after first-line chemotherapy.1 Data from the study, published in Lancet Oncology (Feb 2014), demonstrated that compared to docetaxel alone, nintedanib* when added to docetaxel significantly extended median overall survival from 10.3 to 12.6 months (p=0.0359; HR: 0.83) for patients with adenocarcinoma, with a quarter of patients surviving for two years or more (survival at 24 months – nintedanib* plus docetaxel, 25.7% of patients vs. placebo plus docetaxel, 19.1% of patients, p=0.0359; HR: 0.83).1 Nintedanib* demonstrated a manageable adverse event profile without further compromising patients’ overall health-related quality of life. Adding nintedanib* to docetaxel did not significantly increase discontinuation rates, compared to docetaxel alone.1 Nintedanib* is an oral, twice-daily treatment and is the second approved compound in the Boehringer Ingelheim oncology portfolio. GIOTRIF® (afatinib‡) was the first oncology drug from the portfolio to be approved to treat non-small cell lung cancer patients with distinct types of EGFR-mutation positive NSCLC. About Vargatef® (nintedanib*) Nintedanib* is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. Growing scientific evidence shows that these three different angiokinase receptors play an important role not only in angiogenesis but also in tumour growth and metastasis.4,5 Nintedanib* is currently being investigated in patients with various solid tumours including Phase III studies in advanced NSCLC1, colorectal cancer (refractory to standard treatment)6 and ovarian cancer7, and also in Phase II studies in mesothelioma8, kidney cancer (renal cell carcinoma)9 and liver cancer (hepatic cell carcinoma)10. In the EU, nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF) has recently received a positive CHMP opinion. The U.S. Food and Drug Administration (FDA) has approved nintedanib* capsules under the brand name OFEV® for oral use for the treatment of IPF. About the LUME-Lung 1 trial LUME-Lung 1 is a randomised, double-blind, Phase III study comparing nintedanib* plus docetaxel in patients with locally advanced/metastatic NSCLC after first-line therapy, with placebo plus docetaxel.1 The study included 1,314 patients, in Europe, Asia and South Africa, randomised to receive nintedanib* 200mg twice daily plus docetaxel 75mg/m2 once a day, for 3 weeks (n=655) or placebo plus docetaxel (n=659).1 欧盟批准勃林格抗癌药Vargatef用于非小细胞肺癌 2014年11月28日,欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已建议批准抗癌药物Ofev（nintedanib）用于特发性肺纤维化（IPF）的治疗。 近日，欧盟委员会（EC）已批准nintedanib联合多西紫杉醇（docetaxel）用于一线化疗后腺癌肿瘤学为局部晚期或转移性复发性非小细胞肺癌（NSCLC）患者的治疗，品牌名为Vargatef。 nintedanib联合化疗，是首个在起始化疗失败的广泛腺癌群体中延长患者生存期超过1年的肺癌药物。nintedanib是勃林格殷格翰肿瘤学管线中的第2种抗癌药，首个肿瘤学药物Giotrif（afatinib）于2013年获批在美欧2大主要市场上市，用于携带激活性EGFR突变的局部晚期或转移性非小细胞肺癌（NSCLC）初治成人患者的治疗。 Vargatef（nintedanib）的获批，是基于一项国际性、双盲III期LUME-Lung 1研究的数据，这是在广泛的二线腺癌患者群体所开展的、附加疗法表现出相对于活性对照组具有生存利益的首个试验。该项试验在NSCLC患者中开展，与安慰剂+多西紫杉醇组相比，nintedanib+多西紫杉醇治疗组疾病无进展生存期（PFS）表现出统计学意义的显著延长（3.4个月 vs 2.7个月），肿瘤再度生长风险降低21%，总生存期（OS）显著延长（12.6个月 vs 10.3个月），平均延长20%。此外，数据还表明，腺癌患者越早发生一线化疗失败，nintedanib所带来的临床益处越大，在初始一线治疗后9个月内（T＜9个月）疾病恶化的患者，平均总生存期取得了3个月的临床益处（10.9个月 vs 7.9个月）。 Nintedanib是一种口服三联血管激酶抑制剂，可同时阻断3种生长因子受体：血管内皮生长因子受体（VEGFR 1-3）、血小板源性生长因子受体（PDGFR α和β）、成纤维细胞生长因子受体（FGFR 1-3）。所有这3种受体在血管生成和肿瘤生长过程中均发挥着重要作用。这些受体的阻断，可能导致血管生成的抑制，而血管生成在肿瘤生长中起着关键作用。 在欧盟，CHMP近日已建议批准nintedanib用于特发性肺纤维化（IPF）的治疗。在美国，FDA已批准Ofev（nintedanib）用于特发性肺纤维化（IPF）适应症，同时获批的还有罗氏和InterMune的另一款特发性肺纤维化（IPF）药物Esbriet（比非尼酮）。 目前，勃林格殷格翰正在多种实体瘤中评价nintedanib，其中非小细胞肺癌（NSCLC）、结直肠癌、卵巢癌已处于III期临床，间皮瘤、肾癌（肾细胞癌）、肝癌（肝细胞癌）处于II期临床。 |