Enhertu FDA Approvals for Early Breast Cancer

Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca, has received two new approvals from the United States — Food and Drug Administration. These approvals are for the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer. The neoadjuvant approval is for adult patients with HER2-positive stage 2 or stage 3 breast cancer, while the adjuvant approval is for adult patients with HER2-positive breast cancer who have residual invasive disease after prior neoadjuvant therapy. These approvals are based on positive results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, which demonstrated significant improvements in pathologic complete response and invasive disease-free survival, respectively. Following these approvals, AstraZeneca will pay Daiichi Sankyo $155 million in milestone payments, and Daiichi Sankyo will recognize the sales of Trastuzumab deruxtecan in the U.S. This expansion into early-stage breast cancer treatment positions Trastuzumab deruxtecan as a potential new standard of care, offering new hope for patients and families.