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.

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

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: ...

Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...

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

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

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

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

The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...

A new review was published in Oncotarget's Volume 16 on January 20, 2025, titled "Evolving concepts in HER2-low breast cancer: Genomic insights, definitions, and treatment paradigms." ...

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