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Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

Daiichi Sankyo-阿斯利康的Enhertu在美国获得肺癌优先审查
Benzinga Real-time News ·  2022/04/19 07:15
  • The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting.
  • The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy. 
  • The application has also been granted Priority Review.
  • Related: AstraZeneca's Stock Gain After Enhertu Meets Primary Endpoint In HER2-Low Breast Cancer Setting.
  • The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022.
  • The sBLA is based on data from the registrational DESTINY-Lung01 Phase 2 trial.
  • Preliminary results demonstrated a confirmed objective response rate of 54.9% in patients treated with Enhertu (6.4mg/kg). One (1.1%) complete response and 49 (53.8%) partial responses were observed.
  • A confirmed disease control rate of 92.3% was seen, with a reduction in tumor size observed in most patients. 
  • The median duration of response for Enhertu was 9.3 months. The median progression-free survival was 8.2 months, and the median overall survival was 17.8 months.
  • Price Action: AZN shares are up 0.17% at $68.73 during the premarket session on the last check Tuesday.
  • FDA已接受审查阿斯利康(纳斯达克：azn)-第一三共的(场外交易代码：DSNKY)用于非小细胞肺癌(NSCLC)治疗的Enhertu(曲妥珠单抗)的补充生物制品许可证申请(SBLA)。
  • 该应用涵盖无法切除或转移性非小细胞肺癌，其肿瘤具有HER2(ERBB2)突变，并曾接受过系统治疗。
  • 该申请还获得了优先审查。
  • 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.
  • 处方药使用费法案(PDUFA)的日期，也就是FDA做出监管决定的行动日期，是在2022年第三季度。
  • SBLA基于注册Destination-LUNG01第二阶段试验的数据。
  • 初步结果显示，在接受Enhertu(6.4 mg/kg)治疗的患者中，确认的客观有效率为54.9%。完全缓解1例(1.1%)，部分缓解49例(53.8%)。
  • 确诊的疾病控制率为92.3%，在大多数患者中观察到肿瘤大小缩小。
  • Enhertu的中位缓解期为9.3个月。中位无进展生存期为8.2个月，中位总生存期为17.8个月。
  • 价格行动：在周二的盘前交易中，AZN股价上涨0.17%，至68.73美元。
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