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AstraZeneca, Daiichi Sankyo: Enhertu Gets US Approval For HER2-positive Advanced Gastric Cancer

AstraZeneca plc (AZN.L,AZN) and Daiichi Sankyo Co. Limited (DSKYF.PK) announced Monday that Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with previously treated HER2-positive advanced gastric cancer.

The approval by the Food and Drug Administration was based on the positive results from the randomised DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea.

The companies noted that Enhertu is the first HER2-directed medicine approved for patients with gastric cancer in a decade.

Following US approval, AstraZeneca will pay $115 million to Daiichi Sankyo as a combined 2nd-line and 3rd-line milestone payment in HER2-positive gastric cancer. Sales of Enhertu in the US are recognised by Daiichi Sankyo.

The approval is to treat patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen.

In the trial, Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival and objective response rate versus chemotherapy (irinotecan or paclitaxel) in patients with advanced gastric cancer or GEJ adenocarcinoma who had progressed on at least two or more prior regimens including trastuzumab plus a fluoropyrimidine- and platinum-based chemotherapy combination.

In the US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving beyond five years.Approximately one in five gastric cancers are HER2 positive.

Results from the DESTINY-Gastric01 trial were published in The New England Journal of Medicine in June 2020.

The companies noted that this is the second indication approved for Enhertu in the US. Enhertu earlier received approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial.

Enhertu was previously granted Priority Review, Breakthrough Therapy Designation in HER2-positive metastatic gastric cancer and Orphan Drug Designation for gastric cancer by the FDA.

Two additional Phase II trials, DESTINY-Gastric02 and DESTINY-Gastric03, are underway, further evaluating treatment with Enhertu in patients with HER2-positive metastatic gastric cancer.

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