AstraZeneca and Daiichi Sankyo’s Enhertu, in combination with pertuzumab, has been approved by the US FDA to treat adult patients with unresectable or metastatic HER2-positive breast cancer.
The approval follows previous Priority Review and Breakthrough Therapy designations from the FDA. It is based on data from the phase 3 DESTINY-Breast09 trial, which enrolled 1,157 patients across multiple sites in Europe, the US, Asia, Africa and South America.
The trial found that Enhertu in combination wit