FDA扩大Adcetris适应症至III期或IV期经典霍奇金淋巴瘤

2018-03-25 MedSci MedSci原创

美国食品和药物管理局已批准Adcetris(brentuximab vedotin)用于先前治疗或未经治疗的III期或IV期经典霍奇金淋巴瘤(cHL)的成人患者。

美国食品和药物管理局已批准Adcetrisbrentuximab vedotin)用于先前治疗或未经治疗的III期或IV期经典霍奇金淋巴瘤cHL)的成人患者。

Adcetris是抗体和药物的结合体,Adcetris允许抗体将药物导向C淋巴瘤细胞的细胞表面抗原CD30靶标。Adcetris先前已经被FDA批准用于治疗复发后的cHL干细胞移植后的cHL;患者处于复发或进展的高风险时的cHL;其他治疗失败后的全身性间变性大细胞淋巴瘤(ALCL)和其他治疗失败后的皮肤性ALCL

对以前未经治疗的III期或IVcHL的成人患者的批准是基于比较Adcetris联合化疗(阿霉素,长春碱和达卡巴嗪:AVD)与cHL常规化疗方案(ABVD)得来的。该试验测定了无进展生存期(mPFS),考虑了疾病进展时间,发生死亡的时间长短。在接受治疗的1,334例患者中,在患者接受平均6个治疗周期后,与接受ABVD治疗的患者相比,使用Adcetris/AVD治疗的患者的死亡或开始新疗法的可能性降低23%Adcetris/AVD组有117例(18%)患者出现疾病进展、死亡或开始新的治疗,而ABVD组有146例(22%)患者。

原始出处:

https://www.europeanpharmaceuticalreview.com/news/73874/fda-adcetris-hodgkin-lymphoma/

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