WILMINGTON, DE — AstraZeneca and Daiichi Sankyo have secured U.S. approval for DATROWAY as a first-line treatment for certain patients with metastatic triple-negative breast cancer, expanding treatment options in a disease setting where chemotherapy has long been the primary standard of care.
The approval allows use of DATROWAY (datopotamab deruxtecan-dlnk) in adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy, a population representing a substantial portion of advanced triple-negative breast cancer patients.
The Food and Drug Administration granted approval following a Priority Review of data from the Phase III TROPION-Breast02 trial, which compared DATROWAY with chemotherapy in previously untreated patients.
According to trial results, DATROWAY reduced the risk of disease progression or death by 43% compared with chemotherapy and improved median overall survival by five months. The study also reported an objective response rate of 64%, compared with 30% for chemotherapy.
Tiffany Traina, an investigator in the study and head of the Triple-Negative Breast Cancer Clinical Research Program at Memorial Sloan Kettering Cancer Center, said DATROWAY was the first therapy to demonstrate a statistically significant overall survival advantage over chemotherapy in this first-line treatment setting.
“Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy,” Traina said.
Triple-negative breast cancer is considered one of the most aggressive forms of breast cancer and lacks the hormone receptors and HER2 expression targeted by many existing therapies.
The approval adds a third U.S. indication for DATROWAY and strengthens AstraZeneca’s and Daiichi Sankyo’s positions in the growing antibody-drug conjugate market, a segment that has become a major focus of oncology investment and drug development.
The companies said the treatment has also been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a Category 1 preferred first-line option for metastatic triple-negative breast cancer patients who are not eligible for immunotherapy.
Regulatory reviews remain underway in several international markets, including the European Union, China, Japan, Australia, Canada, Singapore, and Switzerland. The U.S. review was conducted under the FDA’s Project Orbis initiative, which allows participating regulators to review oncology therapies concurrently.
DATROWAY is a TROP2-directed antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca.
The therapy is also approved in the United States for certain patients with EGFR-mutated non-small cell lung cancer and for patients with hormone receptor-positive, HER2-negative metastatic breast cancer who have previously received endocrine therapy and chemotherapy.
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