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AstraZeneca, Daiichi Sankyo's Enhertu Nets Second-Line Breast Cancer Approval in China

NEW YORK – China's National Medical Products Administration (NMPA) on Friday approved AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) as treatment for patients with previously treated advanced HER2-positive breast cancer.

Chinese regulators based the approval — which is for patients who previously received at least one HER2-directed therapy — on the results of the Phase III DESTINY-Breast03 clinical trial. In that study, Enhertu reduced patients' risk of disease progression or death by 72 percent versus Genentech's competing drug Kadcyla (trastuzumab emtansine).

The US Food and Drug Administration and the European Commission both approved Enhertu in the second-line setting for advanced HER2-positive breast cancer last year. This is the first time Enhertu has received approval in China.

"This first approval of Enhertu in China represents a significant advance in the treatment of HER2-targetable tumors and provides the opportunity for patients with previously treated HER2-positive metastatic breast cancer to benefit from this important medicine as a second-line therapy," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said in a statement. "The approval underscores our commitment to patients in China, where there has been an increased incidence rate of breast cancer, as we continue to explore the potential benefits of Enhertu earlier in the treatment of HER2-directed metastatic breast cancer and across HER2-targetable cancers."