The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.
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: ...
Daiichi Sankyo has announced that Hiroyuki Okuzawa will succeed Sunao Manabe as chief executive officer from 1 April 2025.
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...
Alongside margin recovery, Biocon Biologics has also gained market share, with oncology remaining a key focus area.
The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with ...
Updated results from the KATHERINE trial showed that adjuvant T-DM1 provided a significant improvement in overall survival and no evidence of long-term safety issues.
The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...
Adjuvant ado-trastuzumab emtansine significantly prolonged survival compared with trastuzumab for certain women with ...
Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...