Given the evolving role of trastuzumab deruxtecan (Enhertu) in the treatment of breast cancer, especially those who are HER2 ...

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

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

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

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 FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

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.

Trastuzumab deruxtecan is under clinical development by Daiichi Sankyo and currently in Phase I for Esophageal Cancer. According to GlobalData, Phase I drugs for Esophageal Cancer have an 80% phase ...

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