Medically reviewed by Doru Paul, MD Immunohistochemistry (IHC) is a special test used by pathologists to detect specific ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...

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

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

New approval brings the medicine to an earlier treatment setting and a broader patient population.

Roche has secured CE mark approval for its immunohistochemistry (IHC) companion diagnostic test, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, for the identification of epithelial ovarian cancer (EOC ...

The availability of a simple immunohistochemical (IHC) test for HER2-low status is seen as critical to the successful rollout of Enhertu (trastuzumab deruxtecan) in this category of breast cancer ...

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