FDA批准了针对RET基因突变或融合癌症的药物--Retevmo

2020-05-09 MedSci原创 MedSci原创

FDA批准Retevmo用于治疗三种RET基因发生突变或融合的肿瘤--非小细胞肺癌,甲状腺髓样癌和其他甲状腺癌。

美国食品药品监督管理局批准礼来的Retevmo(selpercatinib)用于治疗三种RET基因发生突变或融合的肿瘤--非小细胞肺癌(NSCLC),甲状腺髓样癌(MTC)和其他甲状腺癌。FDA的批准使Retevmo成为首个获批的RET抑制剂。

此次批准是基于Retevmo的一项涉及三种肿瘤的临床试验结果。在临床试验期间,患者每天口服两次Retevmo 160 mg,直至疾病进展或出现不可接受的毒性。疗效的主要指标是总体缓解率(ORR)和缓解持续时间(DOR)。

在105名RET融合阳性NSCLC成年患者中,Retevmo的ORR为64%。在治疗有应答的患者中,有81%的反应持续至少六个月。在未接受过治疗的39例RET融合阳性NSCLC患者中,ORR为84%。治疗有反应的患者中,有58%的反应持续至少六个月。

在143名RET突变的MTC患者中,55名先前接受过治疗的患者ORR为69%。治疗有反应的患者中,有76%的反应持续至少六个月。还评估了88例先前未接受MTC批准疗法治疗患者的疗效,这些患者的ORR为73%,其中治疗有反应的患者中,有61%的反应持续至少六个月。

在RET融合阳性甲状腺癌患者中,之前接受过治疗的19位患者的ORR为79%。治疗有反应的患者中,有87%的反应持续至少六个月。8例除放射性碘治疗以外未接受任何治疗的患者ORR为100%,其中治疗有反应的患者中,有75%的反应持续至少六个月。

原始出处:

https://www.firstwordpharma.com/node/1722921?tsid=4

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    2020-10-16 ysjykql
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    2021-04-24 bugit
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    2020-05-11 licz0427

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