AstraZeneca Gets EU Approval for Breast Cancer Treatment

By Anthony O. Goriainoff

AstraZeneca PLC said Wednesday that Enhertu has been granted conditional approval by the EU as a monotherapy for the treatment for breast cancer.

The U.K. pharmaceuticals giant said the approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial. The company said Enhertu showed "clinically meaningful and durable antitumor activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens."

The company has developed Enhertu--a HER2-directed antibody drug conjugate-- in collaboration with Japan's Sankyo Co. The company said that following EU approval the Japanese company is due a $75-million payment from AstraZeneca as a milestone payment for HER2.

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

(END) Dow Jones Newswires

January 20, 2021 02:33 ET (07:33 GMT)

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