AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens.

The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Gastric06 Phase II trial. Full approval for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lin Shen, MD, Director of the Department of Gastrointestinal Oncology, Peking University Cancer Hospital, China, said: “HER2-positive metastatic gastric cancer can be particularly aggressive and difficult to treat. Patients often face poor outcomes following disease progression on first-line treatment and subsequent chemotherapy. With the approval of Enhertu, patients in China with HER2-positive metastatic gastric cancer will now have an important anti-HER2 treatment option that has demonstrated clinically meaningful efficacy following progression on previous therapies.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “China accounts for more than a third of patients with gastric cancer globally and most patients are diagnosed with advanced disease. This approval of Enhertu brings a much-needed, new targeted treatment option to patients with HER2-positive metastatic gastric cancer in China and underscores our commitment to bringing this innovative medicine to more patients across the globe living with HER2-expressing cancers.”

Kiminori Nagao, Head of the Asia, South & Central America Business Unit, Daiichi Sankyo, said: “This milestone marks the third approval in China for Enhertu in less than two years, following approvals for HER2-positive metastatic breast cancer and HER2-low metastatic breast cancer. Our DESTINY clinical trial programme continues to reinforce Enhertu as a practice-changing treatment option for patients with HER2-expressing cancers and this latest approval in China further illustrates the global impact of this innovative antibody drug conjugate.”

Enhertu is already approved for advanced or metastatic gastric cancer in more than 45 countries, including the US, Japan and across the EU.