AstraZeneca's (LSE:AZN) cancer drug Datroway (datopotamab deruxtecan) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending approval as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who cannot receive immunotherapy.
The recommendation, based on the TROPION-Breast02 Phase III trial, positions Datroway as potentially the first TROP2-directed antibody drug conjugate to demonstrate an overall survival benefit in this EU patient population.
In the trial, Datroway extended median overall survival by 5.0 months compared to chemotherapy, at 23.7 months versus 18.7 months, with a hazard ratio of 0.79. The drug also cut the risk of disease progression or death by 43%, and produced an objective response rate of 62.5% against 29.3% for chemotherapy.
"Today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years," said Susan Galbraith, AstraZeneca's Executive Vice President for Oncology and Haematology R&D, calling the CHMP opinion "an important step forward."
Datroway received US approval for the same indication in May. Regulatory reviews are also underway in China, Japan, Australia, Canada, Singapore and Switzerland.
