On 13 August, AstraZeneca announced that the National Medical Products Administration (NMPA) in China has given conditional approval for the use of Enhertu (trastuzumab deruxtecan) as a monotherapy treatment for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior treatment regimens. Final approval in China for this indication will depend on its success in a confirmatory clinical trial.
Enhertu is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
Enhertu was approved in China for HER2-low breast cancer in July 2023.