On 14 October 2024, AstraZeneca, in partnership with Daiichi Sankyo, announced that Enhertu® (trastuzumab deruxtecan) has received conditional approval in China for use as monotherapy in patients with unresectable, locally advanced or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations and who have already undergone systemic therapy. Final approval of this indication depends on the success of the drug in a confirmatory clinical trial.
In August this year, Enhertu® was conditionally approved in China 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. Enhertu® has previously been approved for HER2-low breast cancer in Japan (March 2023), China (July 2023) and the US (August 2022).