Endocrinology Advisor15h
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.
Zymeworks: Its Post-Approval Future
Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to read why ZYME stock is a Hold.
FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
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 ...
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 ...
pharmaphorum1d
Boost to Enhertu's prospects as FDA clears Roche diagnostic
Enhertu's approval in HER2-ultralow metastatic breast cancer came on the back of the DESTINY-Breast06 trial, which also supported another new indication for the ADC as a second-line treatment for ...
pharmaphorum1d
EU clears Enhertu for HER2-low breast cancer
metastatic breast cancer who received multiple lines of prior treatment, and was headlined at last year's ASCO congress. In the 557-patient study, Enhertu reduced the risk of disease progression ...