26th Jan 2023 09:40
(Alliance News) - AstraZeneca PLC on Thursday said its cancer drug Enhertu, which it develops with Daiichi Sankyo Co Ltd, has been approved in the EU for the treatment of metastatic breast cancer.
The Cambridge-based pharmaceutical company said the approval is the first for HER2-directed therapy for patients with human epidermal growth factor receptor 2-low metastatic breast cancer. Enhertu is an antibody-drug conjugate.
The approval was based on results from study Destiny-Breast04, which showed a risk of disease progression or death by 50% as well as increased overall survival by more than six months compared to chemotherapy.
"A median progression-free survival of 9.9 months was seen with Enhertu versus 5.1 months in those treated with chemotherapy, as assessed by blinded independent central review," AstraZeneca explained.
Dave Fredrickson, executive vice president of AstraZeneca's Oncology Business unit, said: "Historically, patients with breast cancer who have tumours with low levels of HER2 expression have been classified as HER2-negative, giving them limited treatment options beyond chemotherapy. This approval reinforces the important role Enhertu may have for patients with HER2-low disease and highlights the need to evolve the way breast cancer is treated to improve patient outcomes.”
AstraZeneca shares were 0.03% higher at 10,814.00 pence each in London on Thursday morning, while Daiichi shares were 0.3% lower at JPY4,377.00 in Tokyo.
By Tom Budszus, Alliance News reporter
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