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

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

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

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

This study presents a useful finding that targeting amino acid metabolism can overcome Trastuzumab resistance in HER2+ breast cancer. The evidence supporting the claims of the authors is solid and the ...

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

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

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

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

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.