AstraZeneca PLC (LON:AZN) said Enhertu has been approved in the US for the treatment of patients with a certain type of stomach cancer.
The drug, developed with Japanese firm Daiichi Sankyo, can be now used to treat adults with locally advanced or metastatic tumours that have higher than normal levels of a protein called HER2, and have already been treated with an antibody called trastuzumab.
READ: AstraZeneca says EU, UK approve cancer drug for additional dosing option
In the US, gastric cancer is most frequently diagnosed in the advanced stages, with only approximately 5% of patients surviving beyond five years, while one in five gastric cancers are HER2 positive.
The approval by the Food and Drug Administration was based on the positive results from a trial conducted in Japan and South Korea, the FTSE 100 pharma giant said, where Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival and objective response rate versus chemotherapy.
"Patients with metastatic HER2-positive gastric cancer with progression following 1st-line treatment have historically faced poor outcomes, including low response to treatment and rapid disease progression,” said Ronan Kelly, Director of the Charles Sammons Cancer Center and the Chair of Immunology at Baylor University Medical Center, Texas, US, in a release.
“This approval represents the first time a HER2-directed medicine has demonstrated a significant improvement in survival compared to chemotherapy following initial treatment in the metastatic setting, and it has the potential to become the new standard of care for this patient population."
Shares rose 1% to 7,639p early on Monday.
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