關(guān)鍵詞： Genetech 慢性淋巴細(xì)胞白血病 GA101
2013年2月2日訊 /生物谷BIOON/ --Genetech公司透露旗下研制的治療慢性淋巴細(xì)胞白血病新藥GA101又稱obinutuzumab目前研究進(jìn)行順利,，接下來(lái)將對(duì)GA101進(jìn)行更為深入的研究以評(píng)估這種新藥能否與目前廣泛使用的Rituxan相媲美。Genetech表示,，實(shí)驗(yàn)中結(jié)合使用化療藥物和GA101的患者相較于只使用化療藥物的患者有明顯好轉(zhuǎn),。
目前治療慢性淋巴細(xì)胞白血病最有效的藥物是由Genetech和Biogene開(kāi)發(fā)的藥物Rituxan，但是這種藥物將在歐洲的專利將于2013年底到期,。GA101如果研發(fā)成功將減小Rituxan專利到期的影響,。（生物谷Bioon.com）
詳細(xì)英文報(bào)道：
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.
