AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has secured US FDA nod for use in adults with metastatic triple-negative breast cancer (TNBC).
The clearance opens a new treatment path in a setting long dominated by chemotherapy, a decision bolstered by data from the TROPION-Breast02 Phase III trial.
Clinical leaders and patient advocates are calling the approval a turning point.
Tiffany A. Traina of Memorial Sloan Kettering Cancer Centre and investigator for TROPION-Breast02, said: “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. This approval will bring a much-needed treatment option for these patients.”
From the patient advocacy side, Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, highlighted the long-standing treatment gap, saying: “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."
"...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.”
Pharmaceutical leadership at AstraZeneca and Daiichi Sankyo emphasized both the clinical urgency and broader ambition for the therapy.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival.
"With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumours, stages and settings.”
Ken Keller, Global Head of c Business, and President and CEO, Daiichi Sankyo, Inc., said: “As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, Datroway has the potential to redefine the treatment landscape for these patients.
"With this approval, Datroway is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumour types.”
The approval is underpinned by strong Phase III results. In TROPION-Breast02, Datroway delivered a statistically significant 5.0-month improvement in median overall survival and reduced the risk of disease progression or death by 43% compared with chemotherapy.
