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

The FDA has approved a new treatment for patients with a common form of breast cancer that has spread to other parts of the ...

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

T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early 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.

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

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

A phase 3 clinical trial has shown that adding a targeted immunotherapy drug to chemotherapy dramatically improved – almost ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

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