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

The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...

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 ...

HER2-positive breast cancer accounts for 20–30% of all breast cancers and has the second-poorest prognosis among breast cancer subtypes. The approval of trastuzumab in 1998 has significantly improved ...

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

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

Trastuzumab deruxtecan is approved for HR-positive, HER2-low/ultralow metastatic breast cancer post-endocrine therapy, based on DESTINY-Breast06 trial results. The trial showed a 36% reduction in ...

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

At seven-years follow up, invasive disease-free survival was 80.8% with adjuvant T-DM1 and 67.1% with adjuvant trastuzumab alone. Overall survival was 89.1% with T-DM1 and 84.4% with trastuzumab ...

In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine (T-DM1) reduced the long-term risk of death or invasive disease by 46% and ...

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 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 ...