讨论一下有关美罗华第三代GA101，还有美罗华产生耐药后的使用方式。

飞翔的小狗

文章还是2013年的，我们知道ga101是美罗华公司在其第一代专利即将到期后的新产品，之家有位在澳洲的病友参加了实验组治疗结束。不知道有没有这个新药的最新报导和治疗效果？中国什么时候会上市，会是什么价格？
附图是今天看到有关美罗华耐药的文章，我也在想，为什么有很多人用美罗华过敏，有的人没事，除了身体本身差别，医院在用药方法上都有差别，开个玩笑就连滴注的速度都有影响。看看附图，今天才发觉原来辅助用药的作用区别也是很大的，有没有更专业的资料提供下大家来研究一下？是不是一旦耐药就必须换更强的方案，还是存在具体操作上的差别？

美罗华第三代产品GA101Ⅲ期临床研究初步分析达到主要目标
作者：[ 中国肿瘤化疗
中国肿瘤化疗  来源：丁香园   发布日期：2013-2-23
罗氏旗下白血病试验药物GA101（Obinutuzumab）在后期临床试验中能显著提高患者无进展生存期，这也增加了罗氏对公司旗舰产品利妥昔单抗（商品名：美罗华，MabThera）进行后续开发的希望。
该瑞士制药巨头生物部门基因泰克已公开了Ⅲ期临床试验初步数据，数据显示GA101(obinutuzumab)达到了试验的首要目标，与那些仅以化疗进行治疗的患者相比，该药物能够降低慢性淋巴细胞性白血病(CLL)患者的疾病恶化和死亡风险。最终数据分析结果将在今年5月底或6月初公布。
GA101在产品开发时已被特意设计成首个糖基化的，2型抗CD20单克隆抗体，用于治疗B-细胞恶性肿瘤。公司表示，在临床前试验中该药物已显示能增强细胞直接杀死作用和抗体依赖细胞介导的细胞毒作用。
根据罗氏的信息，有迹象显示GA101在治疗慢性淋巴细胞性白血病疗效方面甚至超过一线治疗药物美罗华，但只有当两个药物在下一阶段的临床试验研究项目中针锋相对地对比之后才能明确。罗氏表示将会对GA101进行更为深入的研究以评估这种新药能否与目前广泛使用的美罗华相媲美。
罗氏希望GA101的成功可以帮助缓解公司旗下销售额最大的产品利妥昔单抗（美罗华）仿制药所带来的冲击，这种药物将在欧洲的专利将于2013年底到期。GA101如果研发成功将减小美罗华专利到期的影响。罗氏公司表示计划今年向美国FDA以及欧洲药品管理局（EMA)递交新药上市申请。
GA101治疗非霍奇金淋巴瘤的疗效与安全性评估临床研究还在进行中。
Genentech provided hints that one of the most important experimental cancer drugs in its pipeline performed well in the first part of a two-stage pivotal study in patients on their initial round of treatment for chronic lymphocytic leukemia (CLL). And the U.S. biotech unit of Roche ($RHHBY) is advancing the second stage of the Phase III trial to show whether its new treatment can trump the benefits of blockbuster Rituxan in first-line CLL patients.
Patients on experimental obinutuzumab, or GA101, and the chemo drug chlorambucil lived "significantly" longer without their disease getting worse than those on the chemo med alone in part one of the study, Genentech said. A futility analysis yielded early evidence that the type 2 CD20-targeting therapy could top Rituxan. And gunning for approvals in first-line CLL, the company is sending the results to European and U.S. regulators.
"The improvement in progression-free survival seen with GA101 is encouraging for people with CLL, a chronic illness of older people for which new treatment options are needed," stated Dr. Hal Barron, medical chief and head of global product development for Roche/Genentech. "GA101 demonstrates our ongoing commitment to the research and development of new medicines for this disease."
In a way, Genentech is competing against itself and holding all the good cards in the development of GA101. Rituxan, the multibillion-dollar drug from Genentech and Biogen Idec ($BIIB), is the standard of care for CLL cases that express CD20. However, the blockbuster loses patent exclusivity in Europe in late 2013, and those developing biosimilar versions of the drug aim to grab market share from Biogen and Roche/Genentech.
Genentech, which has a deep pipeline of blood-cancer drugs, plans to reveal detailed data from the Phase III study of GA101 in CLL, called "CLL11," at a future medical meeting. Meantime, industry watchers eagerly await word from the FDA on the company's armed antibody drug T-DM1, which could fuel its dominant position in providing treatments for HER2-positive breast cancer.

金鹿儿

在欧洲，专利药是有专利期限的。

飞翔的小狗

金鹿儿 发表于 2016-8-31 16:50
在欧洲，专利药是有专利期限的。

你说ga101能什么时候上市？

孙生

不知道什么情况～