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US Dato-DXd Approval Relief For AstraZeneca and Daiichi Sankyo

 
• By Alexandra Shimmings

The FDA green light for Datroway in breast cancer marks the first for a TROP2-directed antibody-drug conjugate and is a relief for partners AstraZeneca and Daiichi Sankyo after multiple filing mis-steps in its lung cancer indication.

Digital 3d illustration of cancer cells in human body
• Source: Shutterstock

The US Food and Drug Administration has granted its first approval to AstraZeneca and Daiichi Sankyo’s novel antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), for use in breast cancer. Launch is expected within two weeks.

Key Takeaways

AstraZeneca and Daiichi Sankyo's TROP2-targeted ADC, Datroway, has received its first US approval in breast cancer.

The development is good for sentiment following setbacks for the product in lung cancer

The approval, as Datroway, is specifically for adults with unresectable or metastatic hormone receptor (HR) positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic

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