阿斯利康（易瑞沙厂商）和罗氏（特罗凯厂商）研发跟踪

dunai

本帖用于交流国际大厂靶向抗癌药的最新技术动态，以跟踪新药动态为主。内容都来源于可信的和可引用的出处（如欧洲药品管理局网站、美国食品和药物管理局网站、阿斯利康公司网站、罗氏制药公司网站、国际知名医药新闻网站、维基百科等）。本人先研究了阿斯利康，过段时间研究了罗氏制药后会再加上罗氏的跟踪。

《阿斯利康》

一、Iressa 易瑞沙
（一）EGFR靶向药。根据阿斯利康年报的说法，易瑞沙是EGFR突变为阳性的非小细胞癌的一线治疗药。
（二）该药处于使用期。
（三）该药在欧洲上市；在日本因为副作用遇到了官司，但似乎还在销售；在美国的新药上市申请已经于2011年1月撤回。至于为什么要在美国撤回新药上市申请，http://www.genomeweb.com/dxpgx/a ... ut-refiling-pgx-dat有详细的报道。个人认为这是一个利益斗争的结果，因此中国的患者大可不必关心美国的这些事情。

二、Vandetanib（Zactima）易瑞沙二代、凡德他尼
（一）VEGFR/EGFR靶向药。阿斯利康目前只将该药定义为甲状腺髓样癌的治疗药物。阿斯利康在研究Vandetanib单独使用或与化疗配合使用时对非小细胞癌的治疗，但目前还没有较满意的结果，因此暂没有宣布Vandetanib在非小细胞癌方面的功效。我们将一同期待。
（二）该药处于临床试验三期。
（三）该药在欧洲和美国上市。

三、Recentin
（一）VEGFR靶向药。该药针对非小细胞癌的治疗还在研究中。
（二）该药处于临床试验二期。
（三）该药预计于2016年在欧洲和美国上市。我们期待它尽快在中国上市，祝愿所有的患者可以等到那一天，肺癌将越来越像慢性病。

四、MEDI-575
（一）PDGFR-a靶向药。该药针对非小细胞癌的治疗还在研究中。美国正在召集试验组，预计在2013年会出试验报告。相关链接http://clinicaltrials.gov/ct2/show/NCT01268059。
（二）该药处于临床试验二期，但还没有起名。
（三）该药还没有公布上市时间表。

五、阿斯利康还有十几种抗癌新药处于临床试验一期，其中也许会有很好的肺癌治疗药，我会继续关注。

《罗氏制药》

待续

zachary_cheung

罗氏的赶紧啊，多谢了！

stone3343

楼主你好，凡得他尼治疗肺癌3期临床好像有结果了，结果不乐观啊..你可以简单说说吗？ 谢谢

Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer.
Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD.
Source

Cedars-Sinai Outpatient Cancer Center, 8700 Beverly Blvd, Los Angeles, CA 90048, USA. rnatale@cshs.org
Abstract
PURPOSE:

Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor and epidermal growth factor receptor signaling. This phase III study assessed the efficacy of vandetanib versus erlotinib in unselected patients with advanced non-small-cell lung cancer (NSCLC) after treatment failure with one to two prior cytotoxic chemotherapy regimens.
PATIENTS AND METHODS:

One thousand two hundred forty patients were randomly assigned to receive vandetanib 300 mg/d (n = 623) or erlotinib 150 mg/d (n = 617). The primary objective was to show superiority in progression-free survival (PFS) for vandetanib versus erlotinib. If the difference did not reach statistical significance for superiority, a noninferiority analysis was conducted.
RESULTS:

There was no significant improvement in PFS for patients treated with vandetanib versus erlotinib (hazard ratio [HR], 0.98; 95.22% CI, 0.87 to 1.10; P = .721); median PFS was 2.6 months for vandetanib and 2.0 months for erlotinib. There was also no significant difference for the secondary end points of overall survival (HR, 1.01; P = .830), objective response rate (both 12%), and time to deterioration of symptoms for pain (HR, 0.92; P = .289), dyspnea (HR, 1.07; P = .407), and cough (HR, 0.94; P = .455). Both agents showed equivalent PFS and overall survival in a preplanned noninferiority analysis. Adverse events (AEs; any grade) more frequent with vandetanib than erlotinib included diarrhea (50% v 38%, respectively) and hypertension (16% v 2%, respectively); rash was more frequent with erlotinib than vandetanib (38% v 28%, respectively). The overall incidence of grade ≥ 3 AEs was also higher with vandetanib than erlotinib (50% v 40%, respectively).
CONCLUSION:

In patients with previously treated advanced NSCLC, vandetanib showed antitumor activity but did not demonstrate an efficacy advantage compared with erlotinib. There was a higher incidence of some AEs with vandetanib.

stone3343

好像2期临床效果很好，为什么3期反而不好呢

3v-vvv

太期待了。