Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

The doctor will test the receptors on your cancer. HER2 negative means your breast cancer tissue has little HER2 receptors or the gene that makes the HER2 receptor protein. This will rule out ...

Two dots per cells would signal the presence of the 2 normal HER-2/neu gene copies, and serve as internal control. A clear positive appears as a large gene copy cluster or > 10 signals/nucleus.

The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

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.

Treatment for HER2-positive breast cancer depends on tumor size and spread but may involve a combination of chemotherapy, targeted therapy, monoclonal antibody therapy, and kinase inhibitors.

During a Case-Based Roundtable event, Laura Huppert, MD, discussed data and considerations around using T-DXd in breast ...

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

The researchers found that imlunestrant prolonged progression-free survival (PFS) when compared to standard care in patients with ESR1 mutations, but there was no PFS benefit observed in the overall ...

Enhertu is approved for HR-positive, HER2-low or -ultralow metastatic breast cancer after endocrine therapy progression, based on DESTINY-Breast06 trial results. Enhertu showed a 36% reduction in ...

Itovebi-based regimen significantly improved OS and PFS in PIK3CA-mutated, HR-positive, HER2-negative breast cancer patients. The FDA approved the Itovebi-based combination in October 2024 for ...

In addition, the basal expression of HER-2/neu offers an intrinsic control to calibrate the assay (2 copies/nucleus). The use of fluorescent dyes, however, restricts use of FISH to laboratories ...