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AstraZeneca, Daiichi Sankyo's Datroway Gets US FDA Approval for Advanced Breast Cancer Treatment
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AstraZeneca, Daiichi Sankyo's Datroway Gets US FDA Approval for Advanced Breast Cancer Treatment
Jan 21, 2025 8:11 AM

10:49 AM EST, 01/21/2025 (MT Newswires) -- 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 ( AZN ) 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 ( AZN ) were up 1.9% in recent Tuesday trading.

Price: 67.85, Change: +1.25, Percent Change: +1.88

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