Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

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

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

Trastuzumab, tested only as a single agent, has been shown to achieve 7% response in heavily pretreated patients with AOC with 3+ and 2+ HER2 immunostaining by immunohistochemistry (IHC).

The US Food and Drug Administration (FDA) has approved a label expansion for Roche’s PATHWAY anti-HER2/neu (4B5 ... or metastatic HER2-positive (IHC 3+) BTC. Biliary tract cancers represent ...

[18] Although it is not mandatory to follow the guidelines, they certainly are of utmost help to all surgical or molecular pathology laboratories that perform HER2 testing in their daily practice.

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: ...

2 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).

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

DATROWAY ® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ ...

DATROWAY ® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0 ...