论文部分内容阅读
2014年7月,欧盟委员会(EC)批准Stivarga治疗无法耐受imatinib和sunitinib以及使用imatinib和sunitinib后再次恶化、不可切除或转移性胃肠道间质瘤(GIST)。本品获批用于GIST是基于关键Ⅲ期研究(GRID)结果证实本品用于之前治疗后出现恶化GIST患者时,与安慰剂相比,可明显改善患者的无进展生存期(PFS),差异具有统计学意义。本品已在欧盟获批治疗转移性结直肠癌(mCRC)。
In July 2014, the European Commission (EC) approved Stivarga to treat patients who were unable to tolerate imatinib and sunitinib as well as re-worsening, unresectable or metastatic gastrointestinal stromal tumors (GIST) after using imatinib and sunitinib. This product is approved for use in GIST Based on the pivotal phase III study (GRID) results confirmed that the product used in the treatment of patients with advanced GIST after treatment, compared with placebo, can significantly improve the patient’s progression-free survival (PFS) The difference was statistically significant. This product has been approved in the EU for the treatment of metastatic colorectal cancer (mCRC).