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辉瑞公司于近日宣布,该公司的新一代酪氨酸激酶抑制剂(TKI)英立达(阿昔替尼)获得中国国家食品药品监督管理总局(CFDA)批准,用于既往接受过一种酪氨酸激酶抑制剂或细胞因子治疗失败的进展期肾细胞癌(RCC)的成人患者。该获批基于一项全球国际多中心Ⅲ期研究(AXIS研究)和在亚洲区域采用相似的设计开展的一项国际多中心研究的临床数据。与索拉非尼相比,英立达使中位无进展生存期(PFS)显著延长43%。亚洲区域国际多中心研究获得的临床数据与全球国际多中心Ⅲ期研究
Pfizer recently announced that its new generation of tyrosine kinase inhibitors (TKIs), British Litas (Axitinib), has been approved by China’s State Food and Drug Administration (CFDA) for receiving a past-type of cheese Adult patients with advanced renal cell carcinoma (RCC) who have failed to treat aspartate kinase inhibitors or cytokines. The approval is based on clinical data from an international multicentre Phase III study (AXIS study) and an international multicenter study with similar designs in Asia. In contrast to sorafenib, Infineter significantly prolonged its median progression-free survival (PFS) by 43%. Clinical Data from International Multi-center Study in Asia Region and Global International Multi-Center Phase III Study