Daiichi Sankyo’s Trastuzumab Deruxtecan for HER2-Positive Gastric Cancer Submitted for Priority Review in China

Intelligent Finance APP learned on November 6 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the new indication application for Daiichi Sankyo's trastuzumab deruxtecan injection is proposed to be included in the priority review.Monotherapy is indicated 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.Public information shows that Trastuzumab Deruxtecan (Enhertu) is jointly developed by AstraZeneca (AZN.US) and Daiichi Sankyo.A HER2-targeted antibody-drug conjugate (ADC) that has previously been approved in China for the treatment of HER2-positive and HER2-low adult breast cancer patients.

2023FebruaryTrastuzumab deruxtecan has been approved in China for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies; in the same yearJuly, the new indication for this product has been approved again. It is indicated as monotherapy for adult patients with unresectable or metastatic HER2-low breast cancer who have received at least one systemic therapy in the metastatic setting or relapsed during or within 6 months after adjuvant chemotherapy. According to the CDE announcement,Trastuzumab deruxtecan granted priority review for HER2-positive adult gastric or gastroesophageal junction adenocarcinoma.