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(Alliance News) - AstraZeneca PLC on Monday said its cancer drug conjugate received priority review by the Food & Drug Administration in the US for patients with metastatic HER2-positive solid tumours.
The Cambridge, England-based pharmaceutical company said Enhertu, which it develops together with Tokyo-based partner Daiichi Sankyo Co Ltd, could be the first HER2-directed treatment and antibody drug conjugate to receive a tumour-agnostic indication.
Enhertu is used to treat some forms of breast cancer.
The company said the joint supplemental biologics license application with Daiichi has been accepted for priority review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.
Susan Galbraith, executive vice president of AstraZeneca's oncology research & development unit, said: "Today's priority review for the first tumour-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers. Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumour types. We will continue working closely with the FDA to bring this potential first tumour-agnostic HER2-targeted medicine and biomarker to patients as quickly as possible."
AstraZeneca said the regulatory decision by the FDA is due in the second quarter of 2024.
AstraZeneca shares were flat at 10,544.00 pence each on Monday morning in London, while Daiichi shares closed 1.5% higher at JPY4,345.00 each in Tokyo.
By Tom Budszus, Alliance News slot editor
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