The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a third-line treatment for locally advanced or metastatic HER2 positive adult gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) patients.
Enhertu’s Approval History and Current Indications
Enhertu was first approved in China in February 2023 for the treatment of unresectable or metastatic HER2 positive adult breast cancer patients who had previously received one or more anti-HER2 drugs. Building on this, in July this year, Enhertu earned approval for use as a monotherapy for adult patients with unresectable or metastatic HER2-low breast cancer. This includes patients with metastatic disease or those who have experienced disease recurrence within six months of completing adjuvant chemotherapy.
Ongoing Clinical Studies for Enhertu
Multiple clinical studies for Enhertu are ongoing, targeting a range of other cancers such as non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC). These studies aim to expand the treatment options for patients with these diseases and further establish Enhertu as a significant therapy in the oncology space.-Fineline Info & Tech
