AstraZeneca PLC (LON:AZN) said its Enhertu drug has been approved in the EU to treat a certain type of breast cancer.
The drug, developed with Japanese firm Daiichi Sankyo, can be now used to treat adults with tumours that have higher than normal levels of a protein called HER2, are metastatic or cannot be surgically removed.
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Patients will also need to have previously received two or more therapies targeting the protein HER2.
In Europe, around 531,000 women are diagnosed annually with breast cancer, with an estimated one in five cases being HER2-positive, causing over 141,000 deaths.
The approval follows a phase II trial where Enhertu showed clinically meaningful and durable antitumour activity, and the December 2020 recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
"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,” said the FTSE 100 firm’s executive vice president of the oncology business unit, Dave Fredrickson, in a release.
“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."