Endocrinology Advisor1d
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
Enhertu (fam-trastuzumab deruxtecan-nxki) has received FDA approval for HR-positive, HER2-low, HER2-ultralow metastatic breast cancer.
Targeted Oncology2d
The Targeted Pulse: The FDA Grants MB-105 ODD, and AI Helps Distinguish HER2 0 From 1+ in Breast Cancer
The FDA made strides in R/R T-cell lymphoma and breast cancer. An AI tool aids pathologists and other positive updates in gastric cancer and NSCLC.
Targeted Oncology5d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
oncnursingnews5d
T-DXd Companion Diagnostic in HER2-Ultralow Metastatic Breast Cancer Gains FDA Approval
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.
FierceBiotech6d
Roche's Enhertu companion diagnostic secures new FDA approval in HER2-ultralow breast cancer
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
Pharm Exec6d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...