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

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

Related News: Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Breakthrough Therapy Designation for HER2 Mutant Metastatic Non-Small Cell Lung Cancer

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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