匹衫琼治疗复发难治非霍奇金淋巴瘤

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大家好!刚看到一则新闻，匹杉琼治疗复发难治b细胞非霍已获欧盟批准，心中难免激动，貌似中山大学附属肿瘤医院有这个药的临床试验，群里的盆友有用过这个药的吗？效果怎么样

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到目前为止，欧盟对Pixuvri给予的批准是“有条件”批准，仅限于三线治疗而且要求进一步补充临床数据。FDA在2012年认为药厂提交的Pixuvri的数据“不具有统计学意义”，所以未给予批准，要求做更多的临床试验。2018年7月9日，Pixuvri联合美罗华与吉西他滨比照的III期临床试验的结果出来了，未能达到改善PFS的主要终点。据此，申请FDA批准的可能性基本上不存在了，欧盟也随时有可能撤回原来的批准。

Results of Phase III (PIX306) Trial Evaluating Progression-Free Survival of Pixuvri (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma

SEATTLE, July 9, 2018 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) and Servier today announced that the pivotal Phase III trial (PIX306) evaluating Pixuvri® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of an improvement in progression-free survival (PFS).

"We are disappointed with the outcome of the PIX306 trial and will proceed to conduct a thorough review of clinical data to assess the next steps for the Pixuvri program," commented Adam Craig, MD, PhD, CEO of CTI BioPharma. "We would like to express our appreciation to the patients, families and investigators who participated in the study."

Results from the study will be submitted to a peer-reviewed journal for publication.

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雨丝无愧大神!