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 ...
GlobalData on MSN9d
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from ...
Cure Today11d
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
FierceBiotech3d
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 Exec3d
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 ...
Zacks.com on MSN10d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...
BioPharma Dive9d
Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
AstraZeneca's Enhertu gets additional FDA approval
AstraZeneca (AZN) and Daiichi Sankyo's (DSKYF) drug Enhertu has been approved by the FDA for the treatment of certain breast cancer patients. Read more here.
pharmaphorum5d
Boost to Enhertu's prospects as FDA clears Roche diagnostic
Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...