AstraZeneca: gets EU approval for breast cancer drug
(CercleFinance.com) - AstraZeneca said on Wednesday that a breast cancer drug that it is marketing with Japan's Daiichi has been approved in Europe, cementing the global collaboration deal that the drugmakers signed in 2019
AstraZeneca said that Enhertu has been granted conditional approval for use in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based therapies.
The approval was based on positive results from a Phase II trial, in which Enhertu showed clinically meaningful and durable antitumour activity in patients with HER2-positive metastatic breast cancer.
Enhertu has been approved in the US under accelerated approval, and in Japan under the conditional early approval system.
It is estimated that one in five women with breast cancer have HER2-positive disease.
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