(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Saturday announced that the US Food & Drug Administration has approved their cancer drug conjugate for patients with metastatic HER2-positive solid tumours.

The announcement by the respectively Cambridge, England and Tokyo-based pharmaceutical companies comes after they in January said that Enhertu received priority review from the FDA.

The newest approval for Enhertu is for adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options.

Enhertu is used to treat some forms of breast cancer.

The companies which develop the drug together highlighted that Enhertu now has five approved indications.

Dave Fredrickson, executive vice president of AstraZeneca's Oncology Business unit, said: "As the first antibody drug conjugate to be granted a tumour-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumours. This approval also elevates the importance of testing for biomarkers, including HER2, across a broad range of tumours to ensure these patients with advanced cancer who have few options know whether a targeted medicine might be right for them."

Daiichi Sankyo shares were down 0.1% at JPY4,655.00 each late Monday afternoon in Tokyo. AstraZeneca shares had closed 1.2% lower on Friday in London at 10,610.37 pence each, before the announcement.

By Tom Budszus, Alliance News slot editor

Comments and questions to newsroom@alliancenews.com

Copyright 2024 Alliance News Ltd. All Rights Reserved.