AstraZeneca (AZN) and Daiichi Sankyo's datopotamab deruxtecan, or datroway, has received approval from the US Food and Drug Administration to treat breast cancer patients who have already undergone endocrine-based therapy and chemotherapy.
The approval is based on the results of the Tropion-Breast01 phase 3 trial, which showed a 37% reduction in the risk of disease progression or death, compared with chemotherapy, and a median progression-free survival of 6.9 months versus 4.9 months with chemotherapy, AstraZeneca said in a regulatory filing Monday.
The safety profile of datroway was in line with its known characteristics, with no new safety issues identified, the company added.
Shares of AstraZeneca were up 1.9% in recent Tuesday trading.
Price: 67.85, Change: +1.25, Percent Change: +1.88
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