AstraZeneca PLC on Monday said its breast cancer drug capivasertib in combination with breast-cancer treating hormone therapy drug faslodex has been granted priority review in the US for patients with advanced HR-positive breast cancer.
The Cambridge-based pharmaceutical company said a phase 3 trial showed that the combination reduced the risk of disease progression or death by 40% when compared to faslodex alone.
It said the US Food & Drug Administration accepted its new drug application for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.
The company said the FDA action date for its regulatory decision is in the fourth quarter of 2023.
Susan Galbraith, executive vice president of AstraZeneca’s Oncology research & development unit, said: ‘This priority review decision underscores the potential of capivasertib to extend the effectiveness of endocrine-based treatment approaches for patients with HR-positive breast cancer who experience tumour progression on, or resistance to these widely used therapies.’
AstraZeneca shares were 1.0% higher at 11,832.00 pence each in London on Monday morning.
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