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.

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 ...

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

0001). 2 HER2-low status was defined as immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH]– and HER2-ultralow status was defined as IHC 0 with membrane staining. In the ...

After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA.

Immunohistochemistry and in situ hybridization showed that both multinucleated and mononuclear cells had the same profile: CD138(+), light chain restriction of κ>λ, cyclin D1(+), CD68(-), EBER-ISH (+) ...