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

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 ...

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 ...