23rd Mar 2026 19:13
(Alliance News) - Daiichi Sankyo Co Ltd announced on Monday that Japan's Pharmaceuticals and Medical Devices Agency has approved an update to the prescribing information for its Enhertu treatment, expanding its use to second-line treatment of HER2-positive unresectable advanced or recurrent gastric cancer in Japan.
The Tokyo-based pharmaceutical company has been in collaboration with Cambridge, England-based pharmaceutical company AstraZeneca PLC to jointly develop and commercialise Enhertu since March 2019. According to the company, Enhertu is both the lead cancer therapy in Daiichi Sankyo's oncology portfolio and the most advanced cancer treatment offered by AstraZeneca.
The treatment approval is based on phase 3 trial data showing a 30% reduction in risk of death compared with other treatment options, with median overall survival of 14.7 months versus 11.4 months. The trial enrolled 494 patients in Asia, Europe and South America and had a safety profile consistent with previous trials.
According to the company, the treatment "demonstrated statistically significant and clinically meaningful improvement in overall survival" when compared with alternative treatment options.
Gastric cancer is the third most common cancer in Japan, with 125,000 cases diagnosed in the country in 2022, and more than 43,000 deaths. Globally, gastric cancer is the fifth leading cause of cancer deaths, with a five-year survival rate of 5% to 10%.
"Gastric cancer can be particularly challenging to treat and is associated with poor prognosis," said Yuke Abe, head of research and development in Japan and head of research for Daiichi Sankyo. Abe says the trial data "support the expanded use of Enhertu in Japan, making it available as a new second-line option for patients with HER2 positive metastatic gastric cancer."
Enhertu was previously approved in Japan as a third-line treatment.
Shares in Daiichi Sankyo closed up 2.0% at JPY2,961.00 in Tokyo on Monday, while AstraZeneca closed down 1.1% at 13,740.00 pence in London.
By John Robaina, Alliance News reporter
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