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 ...
[2] Bardia A, et. al. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer, New England Journal of Medicine. 2024; 391:2110-2122 [3] PATHWAY anti-HER-2/neu (4B5) Rabbit ...
Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HE ...
Enhertu (fam-trastuzumab deruxtecan-nxki) has received FDA approval for HR-positive, HER2-low, HER2-ultralow metastatic breast cancer.
This crisis has been worsened by the transition from the NHIF to the Social Health Authority (SHA), which has caused widespread disruptions in healthcare services. Be part of an exclusive group of ...
If you are worried about using this medicine, speak to your doctor or pharmacist. 1. Why am I using Herceptin SC? Herceptin SC contains the active ingredient trastuzumab. Herceptin SC is used to ...
Trastuzumab, tested only as a single agent, has been shown to achieve 7% response in heavily pretreated patients with AOC with 3+ and 2+ HER2 immunostaining by immunohistochemistry (IHC).
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 ...
The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry. Herceptin’s main US patent expires this month ...
Mundipharma has signed a deal with Celltrion to market a biosimilar of Roche’s Herceptin (trastuzumab) in seven European countries. Breast cancer blockbuster Herceptin earned $2.26 billion in ...
The approval of trastuzumab in 1998 has significantly improved patients’ outcomes and paved the way for the beginning of advent of targeted approaches in breast cancer treatment. However, primary or ...
As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow. 1 These patients may now ...