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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獲得第三個乳腺癌突破性治療標籤
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已批准突破性治療指定(BTD)第一三共(場外交易：DSKYF)和阿斯利康(納斯達克代碼：azn)恩海圖(fam-trastuzumab deruxtecan-nxki)用於無法切除或轉移性HER2低(IHC 1+或IHC 2+/ISH陰性)乳腺癌。
  • 這一稱號涵蓋了在轉移環境中接受過系統治療或在輔助化療期間或6個月內出現疾病復發的患者。
  • 相關： 阿斯利康在Enhertu在HER2-低位乳腺癌環境中遇到主要終點後的股票收益.
  • 這是Enhertu在乳腺癌治療中的第三個BTD。Enhertu之前在2021年接受了BTDS治療二線HER2陽性轉移性乳腺癌，並在2017年接受了BTDS治療二線HER2陽性轉移性乳腺癌。
  • 2020年還為ENHERTU額外發放了兩個BTD，用於HER2突變的非小細胞肺癌和HER2陽性的轉移性胃癌。
  • 價格行動：AZN股價週三最後一次開盤前上漲2%，至66.36美元。
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