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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
