20th Jan 2021 08:43
(Alliance News) - AstraZeneca PLC on Wednesday said Enhertu has been granted conditional approval in the EU as a monotherapy to treat adult patients with advanced HER2-positive breast cancer.
Drug maker Astra is jointly developing and commercialising Enhertu, the brand name for trastuzumab deruxtecan, with Daiichi Sankyo Co Ltd.
This recent approval is for patients with unresectable or metastatic - meaning it cannot be surgically removed or has spread to another part of the body - HER2-positive breast cancer, who have received two or more prior anti-HER2-based regimens.
HER2 is a protein expressed on the surface of many tumour types, including breast cancer. Overexpressing HER2 may be associated with a type of HER2 gene alteration called HER2 amplification and is often associated with aggressive diseases as well as a poor prognosis in breast cancer.
The drug, Enhertu, is a HER2-directed antibody drug conjugate, a type of medicine that delivers chemotherapy to cancer cells though a linker attached to a monoclonal antibody. This antibody binds to a specific target expressed on cancer cells.
This EU approval for Enhertu was based on positive results from the Destiny-Breast01 phase 2 trial, where the drug "showed clinically meaningful and durable antitumour activity ". It follows recommendation for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.
Dave Fredrickson, executive vice president of Astra's Oncology Business Unit, said: "Enhertu is already transforming outcomes for patients with HER2-positive metastatic breast cancer in the US and Japan, and this approval enables us to bring the benefits of this medicine to patients in the EU. We will continue to explore the potential of Enhertu in this setting, as well as in earlier lines of treatment and stages of disease, with the ambition of improving the lives of patients with HER2-targetable breast cancer."
Shares in Astra were up 0.1% at 7,728.00 pence in London on Wednesday morning.
By Anna Farley; [email protected]
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