Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

January 18, 2021 Auto Bot AstraZeneca, Daiichi Sankyo, Enhertu, FDA, Metastatic, regulatory 0

Shots:

  • The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult patients with LA or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen
  • In a pre-specified interim analysis, it showed 41% reduction in the risk of death vs patients with mOS (12.5 vs 8.4mos); PFS (5.6 vs 3.5mos); ORR (40.5% vs 11.3%); CR (7.9% vs 0%); PR (32.5% vs 11.3%); DoR (11.3 vs 3.9mos.)
  • Enhertu is a HER2-directed ADC and has received the US FDA’s PR & BTD for HER2+ m-gastric cancer and ODD for gastric cancer

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: BioSpace

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