Daiichi Sankyo/AstraZeneca Submits New NDA for Trastuzumab Deruxtecan in China for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
AstraZeneca
Biopharmaceutical Manufacturer
Daiichi-Sankyo
Pharmaceutical R&D Developer
On December 12, the CDE website showed that Daiichi Sankyo/AstraZeneca's HER2 ADC, Trastuzumab Deruxtecan (Enhertu, DS-8201), had a new indication submitted for marketing approval (acceptance number: JXSS2300089).
PreviouslyTrastuzumab DeruxtecanA new indication has been granted priority review, which is speculated to be for this indication: monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior treatment regimens.
From:CDE Official Website
Trastuzumab Deruxtecan submitted its first marketing application in China in March 2022, was approved for marketing in February this year, and so far has been approved for 2 breast cancer indications: HER2-positive breast cancer and HER2-low breast cancer.
Outside of China, trastuzumab deruxtecan has received regulatory approval for three types of cancer: breast cancer, gastric cancer, and non-small cell lung cancer.
