AstraZeneca breast cancer drug granted priority review by US FDA

Drugmaker AstraZeneca said on Monday that its Enhertu metastatic breast cancer asset had been granted priority review status in the US following results from its DESTINY-Breast04 trial.

AstraZeneca said on Monday that the Food and Drug Administration had agreed to put Enhertu, developed jointly with Japan's Daiichi Sankyo, under priority review for the treatment of adult patients in the US with unresectable or metastatic HER2-low breast cancer who have received a prior therapy in the metastatic setting.

The FTSE 100-listed group also highlighted that Enhertu was the first HER2-directed therapy to demonstrate a survival benefit in the aforementioned population, demonstrating a "superior and clinically meaningful" efficacy in progression-free survival and overall survival.

AstraZeneca's executive vice president of oncology research and development, Susan Galbraith, Executive Vice President, said: "The data from DESTINY-Breast04 represent the first time a HER2-targeted therapy has shown a survival benefit in patients with HER2-low metastatic breast cancer. For more than two decades, only patients with HER2-positive breast cancer have been able to benefit from HER2-targeted therapies.

"If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumours have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy."

Reporting by Iain Gilbert at Sharecast.com