AstraZeneca’s Enhertu Receives Health Canada’s Approval for Expanded Indication in Adults with HER2-Positive Metastatic Breast Cancer
Shots:
- The approval was based on the P-III head-to-head (DESTINY-Breast03) trial that evaluates Enhertu (5.4mg/kg) vs T-DM1 (3.6mg/kg) in 524 patients with HER2+ unresectable & metastatic breast cancer prior treated with trastuzumab & taxane at multiple sites in Asia, EU, North America, Oceania & South America
- The results showed a 72% reduction in risk of disease progression or death, m-PFS (not reached vs 6.8mos.). At the time of the PFS analysis, 16.4% had died, OS was immature, ORR (79.7% vs 34.2%)
- The safety profile was consistent with prior trials. Enhertu is a HER2-directed ADC that consists of HER2 mAb attached to topoisomerase I inhibitor payload, an exatecan derivative via a stable tetrapeptide-based cleavable linker
Ref: AstraZeneca | Image: AstraZeneca
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.