AstraZeneca and Daiichi Sankyo have received FDA approval for DATROWAY (datopotamab deruxtecan-dlnk) for the treatment of metastatic triple-negative breast cancer (TNBC) in patients who are not candidates for immunotherapy – approximately 70% of the metastatic TNBC population for whom chemotherapy was previously the only option.
DATROWAY is the first TROP2-directed antibody drug conjugate to demonstrate a median overall survival of approximately two years in this setting, with a 5-month improvement in median overall survival and a 43% reduction in the risk of disease progression or death compared to chemotherapy. The objective response rate was 64% versus 30% with chemotherapy.
TNBC is the most aggressive form of breast cancer and has one of the worst prognoses, with median overall survival of just 12-18 months and only about 15% of patients living five years after diagnosis. It accounts for approximately 15% of all breast cancer cases and is diagnosed more frequently in younger and premenopausal women, with higher prevalence in Black and Hispanic women.
“Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the first-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy,” said Tiffany A. Traina, MD, section head of the Triple-Negative Breast Cancer Clinical Research Program at Memorial Sloan Kettering Cancer Center.
“For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option,” said Arlene Brothers, executive director of the Triple Negative Breast Cancer Foundation. “Today’s approval of DATROWAY means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.”
DATROWAY now holds three U.S. indications including TNBC, HR-positive/HER2-negative breast cancer, and EGFR-mutated non-small cell lung cancer. The approval follows Priority Review and was reviewed under Project Orbis, with reviews ongoing in Australia, Canada, Singapore, Switzerland, the EU, China, and Japan.
