AstraZeneca and Daiichi Sankyo get new approval in China for Enhertu

(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Tuesday said their joint product Enhertu has received a third approval in China.

Enhertu, whose generic name is trastuzumab deruxtecan, has been given conditional approval from the National Medical Products Administration for the treatment of gastric cancer.

The new indication is as a monotherapy for the treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma, who have received two or more prior treatment regimens.

The approval is based on the Destiny-Gastric06 trial, in which Enhertu demonstrated clinically meaningful efficacy for such patients.

"HER2-positive metastatic gastric cancer can be particularly aggressive and difficult to treat," said Lin Shen, director of Gastrointestinal Oncology at Peking University Cancer Hospital. "Patients often face poor outcomes following disease progression on first-line treatment and subsequent chemotherapy."

The gastric cancer approval is the third in China for Enhertu in less than two years, Astra and Daiichi Sankyo noted, following approvals for HER2-positive metastatic breast cancer and HER2-low metastatic breast cancer.

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

AstraZeneca were up 0.2% to 12,800.00 pence on Tuesday morning in London. Daiichi Sankyo shares closed down 0.9% at JPY1,547.00 in Tokyo.

By Tom Waite, Alliance News editor

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