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靶向HER2的抗体药物偶联物ENHERTU获得FDA授予突破性疗法称号,治疗HER2阳性转移性非小细胞肺癌

2020-05-19 MedSci原创 MedSci原创

Enhertu已经获得了FDA授予针对HER2阳性乳腺癌、胃癌和非小细胞肺癌的突破性疗法称号。

阿斯利康(AstraZeneca)和第一三共(Daiichi Sankyo)公司的靶向HER2的抗体药物偶联物ENHERTU(FAM-trastuzumab deruxtecan-nxki),在治疗HER2阳性的转移性非小细胞肺癌(NSCLC)方面获得了美国食品药品管理局(FDA)的突破性疗法称号(BTD)。

去年12月,Enhertu首次获得FDA的批准,用于治疗先前已接受过两种或多种基于抗HER2疗法的转移性HER2阳性乳腺癌患者。

Enhertu已经获得了FDA授予针对3种癌症的BTD称号,该药物本周在HER2阳性的转移性胃或胃食管交界性腺癌中也获得了BTD称号。

先前还获得了HER2阳性乳腺癌的BTD称号,促使Enhertu治疗HER2阳性乳腺癌在12月份得到了加速批准。

据第一三共制药公司称,目前在全球范围内正在进行六项Enhertu的关键性试验,涉及多种HER2阳性癌症,例如乳腺癌、胃癌和肺癌。Enhertu与其他抗癌疗法(包括免疫疗法)联合使用的试验也正在进行中。

原始出处:

http://www.pmlive.com/pharma_news/az,_daiichi_sankyos_enhertu_fast-tracked_in_us_for_nsclc_1340453

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    2020-05-19 lhlxtx
  3. 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  5. 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  6. 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  7. 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ASCO 2020:罗氏的TIGIT单抗tiragolumab与PD-L1单抗Tecentriq联合,延长了非小细胞肺癌患者生存期

TIGIT靶向抗体tiragolumab与Tecentriq组合能够提高NSCLC患者的客观缓解率和无进展生存期。

Lancet Oncol :Atezolizumab联合卡波铂和nab-paclitaxel用于非小细胞肺癌术前化疗

Atezolizumab联合卡波铂和nab-paclitaxel治疗可作为可切除非小细胞肺癌术前化疗的新辅助治疗方案,有很高比例的患者获得了病理反应

美国批准PD-L1单抗Tecentriq,用于非小细胞肺癌的一线治疗

在美国,PD-L1单抗Tecentriq(atezolizumab)已获得NSCLC的四项批准。

NAT MED:我国公布CRISPR人体试验结果

在此,我国研究人员报告了CRISPR-Cas9 PD-1编辑的T细胞在晚期非小细胞肺癌患者中的首例人体I期临床试验的结果(ClinicalTrials.gov NCT02793856)。

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