HER2 classification relies on immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), which examines the number of copies of the HER2 gene inside a cancer cell. "On FISH ...

The analysis was performed on independent study sets of HER2-positive and negative/low breast cancers, already analyzed by central immunohistochemistry (IHC) and FISH testing. Phospho-HER2 and ...

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

The Food and Drug Administration (FDA) has approved Datroway ® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human ...

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.

The analysis was performed on independent study sets of HER2-positive and negative/low breast cancers, already analyzed by central immunohistochemistry (IHC) and FISH testing. Phospho-HER2 and ...

The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...