AstraZeneca and Daiichi Sankyo have announced that the U.S. Food and Drug Administration (FDA) has approved DATROWAY (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval makes DATROWAY the first TROP2-directed antibody-drug conjugate (ADC) approved in the United States for first-line treatment in this patient population.
The approval was granted under Priority Review based on results from the Phase III TROPION-Breast02 trial. According to the companies, DATROWAY demonstrated statistically significant and clinically meaningful improvements in both overall survival and progression-free survival compared to chemotherapy. In the study, the drug showed a 5-month improvement in median overall survival and reduced the risk of disease progression or death by 43% versus standard chemotherapy.
Triple-negative breast cancer is considered one of the most aggressive forms of breast cancer because it lacks the hormone receptors and HER2 expression targeted by many existing therapies. Approximately 70% of patients with metastatic TNBC are not eligible for immunotherapy, leaving chemotherapy as the only available first-line treatment option for years.
Tiffany A. Traina, MD, FASCO, from Memorial Sloan Kettering Cancer Center and an investigator in the TROPION-Breast02 trial, stated that datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival compared with chemotherapy in the first-line setting for metastatic TNBC patients who cannot receive immunotherapy.
Arlene Brothers, Executive Director of the Triple Negative Breast Cancer Foundation, said the approval represents a major advance because patients unsuitable for immunotherapy previously had limited treatment choices beyond traditional chemotherapy.
DATROWAY is a specifically engineered TROP2-directed DXd antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca. The medicine targets TROP2 proteins expressed on cancer cells and delivers a topoisomerase-I inhibitor payload directly into tumors.
Ken Keller, Global Head of Oncology Business and President & CEO of Daiichi Sankyo Inc., said DATROWAY has the potential to redefine treatment standards after becoming the first ADC to demonstrate a median overall survival of around two years in the first-line metastatic TNBC setting.
The therapy has also been included in the NCCN Clinical Practice Guidelines as a Category 1 preferred first-line treatment option for metastatic TNBC patients who are not candidates for immunotherapy.
