2013年9月1日讯 -- 拜耳（Bayer）8月30日宣布，口服多激酶抑制剂Stivarga（regorafenib）已获欧盟委员会（EC）批准，用于既往经当前可用疗法治疗过或不适用于当前可用疗法（包括基于氟尿嘧啶的化疗，抗VEGF疗法、抗EGFR疗法）的转移性结直肠癌（mCRC）成人患者的治疗。
Stivarga的获批，是基于关键性III期CORRECT临床试验的数据，结果表明，与安慰剂相比，regorafenib显着延长了总生存期（OS），并显着延缓了癌症的进展。该项研究的完整数据已提交至2012年6月的美国临床肿瘤学会第48届年会，并于2012年11月在线发表于《柳叶刀》（The Lancet）。
Stivarga是首个也是唯一一种在转移性结直肠癌（mCRC）中表现出总生存期益处的多激酶抑制剂，目前，该药已获美国、日本等国批准，用于转移性结直肠癌（mCRC）和胃肠道间质瘤（GIST）的治疗。
在全球范围内，结直肠癌（CRC）是第三种最常见的癌症，每年发生超过100万例，5年生存率平均为55%。
Stivarga是一种口服多激酶抑制剂，在临床前研究中，regorafenib能够抑制数个促血管生成VEGF受体酪氨酸激酶，这些激酶在肿瘤的血管生成中发挥着重要作用。该药还可以抑制癌和肿瘤微环境中的多种激酶，包括VEGFR 1-3, KIT, RET, PDGFR及FGFR。
Stivarga由拜耳开发，由拜耳和Onyx制药联合推广。
Bayer’s Stivarga (regorafenib) Approved in the EU for the Treatment of Metastatic Colorectal Cancer
Berlin, August 30, 2013 – Bayer HealthCare announced today that the European Commission has approved Stivarga? (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy.
“Following the approval of Stivarga for mCRC in several countries worldwide, including the US and Japan, we are pleased to offer patients in Europe a new treatment option”, said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “At Bayer, we are committed to developing treatments that can improve the lives of patients, and from these data anticipate that Stivarga can positively impact those suffering from mCRC.”
“Colorectal cancer is one of the most prevalent cancer types for which there is a real unmet need for new treatment options. Currently people with early CRC can have surgery to remove the cancer, preceded or followed by radiotherapy and/or chemotherapy to prevent it coming back. Yet for many people their disease progresses to other parts of the body, dramatically reducing their chance of being cured,” said Prof. Eric Van Cutsem, Lead CORRECT investigator, University Hospital Gasthuisberg Leuven, Belgium. “The multi-targeted action of Stivarga provides a new option in targeting mCRC. In the CORRECT trial, Stivarga significantly improved both overall and progression-free survival in this difficult-to-treat population. These data show that Stivarga can provide new treatment option for patients with mCRC,” van Cutsem concluded.
The approval of Stivarga was based on data from the pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Full results from the CORRECT study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology in June 2012 and published online on November 22, 2012 in The Lancet.
Stivarga is approved for the treatment of patients with mCRC and gastrointestinal stromal tumors (GIST) in several countries, including the U.S and Japan.
About Colorectal Cancer
CRC is the third most common cancer worldwide, with over one million cases occurring every year. The five-year survival estimate for CRC on average is 55 percent, but is highly variable dependent on the stage of the disease (from 74 percent for patients with Stage I disease to only 6 percent for Stage IV patients).
About Stivarga?
Stivarga? (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including VEGFR 1-3, KIT, RET, PDGFR, and FGFR, which inpidually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.
Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the USA. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
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