The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer. Enhertu, a HER2-directed antibody drug conjugate, is now the first approved therapy for patients with the HER2-low breast cancer subtype. The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for…
FDA grants Enhertu priority review for HER2-positive positive metastatic breast cancer
FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…