FDA Approval Opens Up Gastric Cancer To Daiichi Sankyo/AZ’s Enhertu

Follows Japanese Approval Last September

The two companies can now market their HER-2 targeting antibody-drug conjugate in its second tumor type as they look to expand beyond breast cancer.    

Cancer
• Source: Shutterstock

Daiichi Sankyo Co., Ltd. and AstraZeneca PLC’s antibody-drug conjugate product Enhertu has received an expanded approval from the US Food and Drug Administration for its use in gastric cancer.

The approval was based on data from the DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea and is specifically for its use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal

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