AstraZeneca hails US approval for gastric cancer medicine
The first HER2-directed medicine approved for patients with gastric cancer in a decade – piloted by Cambridge’s AstraZeneca and Daiichi Sankyo – has been sanctioned by the FDA.
Enhertu has been approved in the US for the treatment of adult patients with the disease. In the US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately five per cent of patients surviving beyond five years. Around one in five gastric cancers are HER2 positive.
FDA backing followed positive results from a Phase II trial conducted in Japan and South Korea.
Dave Fredrickson, executive VP of AstraZeneca’s Oncology Business Unit, said: “The approval of Enhertu represents the first HER2-directed medicine approved in a decade for patients with HER2-positive metastatic gastric cancer. We are thrilled to bring this important medicine to more patients and physicians in the US.”
As a result of the FDA decision, AstraZeneca will now pay a further $115 million to Daiichi Sankyo on top of previously honoured payments.