2017年11月15日,制藥巨頭阿斯利康公司在官網(wǎng)上宣布描扯,美國(guó)食品藥品監(jiān)督管理局(FDA)批準(zhǔn)氟維司群(fulvestrant)聯(lián)合abemaciclib治療定页,激素治療后進(jìn)展的HR+趟薄、HER2-晚期或轉(zhuǎn)移性乳腺癌(MBC)。Abemaciclib是CDK4/6抑制劑典徊。
FDA此次的批準(zhǔn)是基于III期MONARCH 2試驗(yàn)結(jié)果杭煎。該試驗(yàn)共納入669名HR+、HER2-晚期乳腺癌患者卒落。接受氟維司群+abemaciclib治療或維司群+安慰劑治療羡铲。結(jié)果顯示,氟維司群+abemaciclib治療的中位無(wú)進(jìn)展生存時(shí)間(PFS)顯著長(zhǎng)于對(duì)照組儡毕,16.4個(gè)月 vs 9.3個(gè)月也切。
參考文獻(xiàn)
Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib [news release]. AstraZeneca: November 15, 2017. https://www.astrazeneca.com/media-centre/press- releases/2017/faslodex-receives-us-fda-approval-for-the-treatment-of-advanced-breast-cancer-in-combination- with-abemaciclib-15112017.html. Accessed November 15, 2017.