Shots:

• The US FDA’s ODD is based on P-II DESTINY-Gastric01 study assessing Enhertu (6.4 mg/kg- q3w) vs CT in 188 patients in a ratio (2:1) with HER2-expressing- advanced gastric cancer- progressed with 2+ prior treatment regimens including 5-FU- Pt. CT and trastuzumab
• The study demonstrated improvement in ORR & OS and will be presented at ASCO20. The designation follows US FDA’s BT designation of Enhertu for HER2+ metastatic gastric cancer and HER2 mutant m-NSCLC
• Enhertu is a HER2 directed ADC- designed utilizing Daiichi Sankyo’s DXd ADC technology and has received MHLW’s SAKIGAKE designation in Mar’2018 for HER2 positive gastric cancer with recently submitted sNDA to MHLW

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Ref: Astrazeneca  | Image: StraitTimes