The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated positive overall survival results.

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The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

The FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer.

T-DXd has received FDA approval for the treatment of unresectable or metastatic HR+, HER2-low/-ultralow breast cancer in ...

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, ...

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...

A new statistical tool that combines multiple clinical and pathologic factors with a patient's 21-gene Oncotype DX Breast ...