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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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