Shots:
- The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions
- Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2 vs 8.1mos. in both HER2-low pts & overall population, with consistent results across both arms in an exploratory analysis; data was presented at ASCO 2024 & published in The NEJM
- Following EC’s Approval, AZ will pay $125M to Daiichi for this milestone under their 2019 collaboration agreement
Ref: AstraZeneca | Image: Daiichi Sankyo & AstraZeneca
Related News:- Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer
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