Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Orphan Drug Designation for Gastric Cancer

Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Orphan Drug Designation for Gastric Cancer

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

Click here to­ read full press release/ article | Ref: Astrazeneca  | Image: StraitTimes

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