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Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

Daiichi Sankyo-阿斯利康的Enhertu获得第三个乳腺癌突破性治疗标签
Benzinga Real-time News ·  2022/04/27 09:30
  • The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo (OTC:DSKYF) and AstraZeneca Plc's (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.
  • The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of adjuvant chemotherapy. 
  • Related: AstraZeneca's Stock Gain After Enhertu Meets Primary Endpoint In HER2-Low Breast Cancer Setting.
  • This is the third BTD for Enhertu in breast cancer. Enhertu previously received BTDs to treat second-line HER2 positive metastatic breast cancer in 2021 and later-line HER2 positive metastatic breast cancer in 2017.
  • Two additional BTDs for ENHERTU were also granted in 2020 for HER2 mutant non-small cell lung cancer and HER2 positive metastatic gastric cancer.
  • Price Action: AZN shares are up 2% at $66.36 during the premarket session on the last check Wednesday.
  • FDA已批准突破性治疗指定(BTD)第一三共(场外交易：DSKYF)和阿斯利康(纳斯达克代码：azn)恩海图(fam-trastuzumab deruxtecan-nxki)用于无法切除或转移性HER2低(IHC 1+或IHC 2+/ISH阴性)乳腺癌。
  • 这一称号涵盖了在转移环境中接受过系统治疗或在辅助化疗期间或6个月内出现疾病复发的患者。
  • 相关： 阿斯利康在Enhertu在HER2-低位乳腺癌环境中遇到主要终点后的股票收益.
  • 这是Enhertu在乳腺癌治疗中的第三个BTD。Enhertu之前在2021年接受了BTDS治疗二线HER2阳性转移性乳腺癌，并在2017年接受了BTDS治疗二线HER2阳性转移性乳腺癌。
  • 2020年还为ENHERTU额外发放了两个BTD，用于HER2突变的非小细胞肺癌和HER2阳性的转移性胃癌。
  • 价格行动：AZN股价周三最后一次开盘前上涨2%，至66.36美元。
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