AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with ...

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).

Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

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 ...

Trastuzumab emtansine (T-DM1) demonstrates sustained improvement in invasive disease-free survival and reduced the risk for death in human epidermal growth factor receptor 2 (HER2)-positive breast ...

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.

The addition of trastuzumab and pertuzumab to chemotherapy was associated with increased toxicity in patients with ...

Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer. New England Journal of Medicine , 2025; 392 (3): 249 DOI: 10.1056/NEJMoa2406070 Cite This Page : ...