Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated ...

The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...

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

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

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

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

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.

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

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

As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be ...

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

Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HE ...