Monthly Prescribing Reference9d
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
Enhertu is supplied in a single-dose vial containing 100mg of lyophilized powder for reconstitution and further dilution prior to IV infusion. Patients should be selected for treatment with ...
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 ...
FierceBiotech1d
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 ...
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...
Yahoo Finance8d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
pharmaphorum3y
Enhertu nabs speedy FDA review for earlier use in breast cancer
Enhertu is already approved as a third-line therapy for HER2-positive breast cancer, but moving the drug up the treatment pathway could make it an option for a larger group of patients and ...
FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...
Healio9d
FDA expands Enhertu approval for breast cancer
Trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a HER2-directed antibody-drug conjugate. The agent is approved in the United States for several indications, including treatment of ...