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

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 FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...

January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.

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.

Trastuzumab deruxtecan is approved for HR-positive, HER2-low/ultralow metastatic breast cancer post-endocrine therapy, based on DESTINY-Breast06 trial results. The trial showed a 36% reduction in ...

Known as fam-trastuzumab deruxtecan but marketed under the brand name Enhertu, it is meant to treat advanced breast cancer that is HR-positive and HER2-low or ultralow, which has not improved ...

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 ...

Enhertu (fam-trastuzumab deruxtecan-nxki) can cause side effects that range from mild to serious. More common side effects include hair loss, nausea, and vomiting. If Enhertu side effects become ...

WILMINGTON, Del., January 27, 2025--AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable ...