AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...

Pathologists supported by a new artificial intelligence tool outperformed Standard of Care/Gold standard in determining ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

The HER2-low and HER2-ultralow breast cancer subtype designations have led to a changed landscape in HER2-directed therapies, as well as a desire for more sensitive assays that may better quantify ...

The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.

Breast cancer classed as HER2-positive - defined as an immunohistochemical (IHC) score of three or more – accounts for somewhere between 20% to 25% of all patients with the disease. However ...