Erlotinib 【药品名称】 Tarceva、OSI-774、埃罗替尼、他西卫、它赛瓦 Erlotinib是第一种表皮生长因子受体（EGFR）酪氨酸激酶抑制剂。Erlotinib在日本的II期临床试验已经完成，在试验中主要对它的疗效和安全性进行检测。结果显示，那些之前接受过化疗但收效甚微的患者使用该药之后，在抗癌效果和耐受性方面都较为理想。 在临床研究中，接受这种新药治疗的患者不仅能够存活更长时间，而且其身体状况也趋于好转。这种药物能延缓病情的进一步发展，咳嗽、呼吸困难、疼痛等肺癌症状出现的时间均明显推后。但erlotinib也会引发腹泻和皮肤的不良反应。Erlotinib已在50多个国家获得批准，今年第一季度该药的销售额几乎增加了一倍，达9300万美元。在2005年11月，该药用于治疗胰腺癌的扩大适应症在美国也获得了批准。有证据显示：erlotinib能提高晚期肺癌患者存活率 FDA approves erlotinib for lung cancer Tyrosine kinase inhibitor approved for treatment of patients with locally advanced or metastatic non杝mall-cell lung cancer. FDA has approved erlotinib (Tarceva—Roche, OSI Pharmaceuticals, and Genentech) for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. NSCLC is responsible for nearly 80% of cases of lung cancer. The drug’s approval was based on results from a Phase III trial involving 731 patients that compared erlotinib with placebo for treatment of patients with advanced NSCLC. The median age of study participants was 61 years, and 64% were men . The drug showed a 42% survival benefit for subjects in the randomized placebo-controlled trial, following failure of first- or second-line chemotherapy. The length of time before patients symptoms deteriorated and the time when patients were stable increased significantly, and cancer did not progress. Patients receiving erlotinib lived significantly longer than those in the placebo arm (6.7 months versus 4.7 months). Erlotinib targets epidermal growth factor receptor (EGFR), which plays a role in the formation and growth of many cancers. Erlotinib blocks tumor cell growth by inhibiting the tyrosine kinase activity of this pathway inside the cell. The drug is well tolerated; rash and diarrhea were the most frequently reported adverse effects. A total of 5% of patients discontinued erlotinib because of adverse effects, compared with 2% of patients on placebo. The Phase III study was conducted by the National Cancer Institute of Canada Clinical Trials Group and investigators from around the world . Erlotinib also is under review for marketing authorization in Europe.