Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Shots:

• The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas
• Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin, capecitabine, vinorelbine or gemcitabine) in HR+/HER2- breast cancer patients (n=732)
• The trial showed improved PFS of 37%, mPFS (1EP; 6.9 vs 4.9mos.), ORR (2EPs; 36% vs 23%) with CR (2; 0.5% vs 0; 0%) & PR (131; 36% vs 84; 23%), plus mDoR (2EPs; 6.7 vs 5.7mos). Safety was favorable in 360 subjects & data was published in JCO

Ref:  Daiichi Sankyo| Image: Daiichi Sankyo & AstraZeneca

Related News:- AstraZeneca and Daiichi Sankyo Report the US FDA’s BLA Acceptance of Datopotamab Deruxtecan with Priority Review for EGFR-mutated NSCLC

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