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

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

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...

AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...

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

Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...

The FY2024 revenue forecast remains unchanged, despite delays in approvals for Datroway in the lung cancer field. Growth is expected to be supported by ENHERTU's continued expansion. Profit ...

Given the evolving role of trastuzumab deruxtecan (Enhertu) in the treatment of breast cancer, especially those who are HER2 positive, staying vigilant in looking for signs of adverse events (AEs) is ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

Study participants with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer ... for Enhertu also includes a Boxed Warning regarding the risk of interstitial lung disease and embryo ...