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

Enhertu (fam-trastuzumab deruxtecan-nxki) has received FDA approval for HR-positive, HER2-low, HER2-ultralow metastatic breast cancer.

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 ...

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

Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

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

The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...

Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY ...

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