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: ...

The global Immunohistochemistry Market is valued at an estimated USD 3.4 billion in 2024 and is projected to reach USD 5.2 ...

Findings showed datopotamab deruxtecan reduced the risk of disease progression or death by 37% compared with chemotherapy.

All positive (IHC 3+) and doubtful (IHC 2+) cases were screened by fl uorescence in situ hybridization (FISH). Patients with HER2 gene amplification, normal left ventricular ejection fraction ...

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

In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA) has ...

Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for ...

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer ...

HER2-low is defined as an IHC result of 1+ or 2+ with a negative in situ hybridization (ISH) test, and HER2-ultralow is defined as IHC 0 with membrane staining. In 2022 and 2023, Enhertu was approved ...