AstraZeneca and Daiichi Sankyo Report the NMPA’s Conditional Approval of Enhertu to Treat Metastatic NSCLC with HER2 Mutations
Shots:
- The NMPA has granted conditional approval to Enhertu as monotx. for treating inoperable, locally advanced or metastatic NSCLC with HER2 (ERBB2) mutations in adults previously treated with Pt-based CT, supported by P-II (DESTINY-Lung02 & DESTINY-Lung05) studies. Full approval depends upon the confirmatory trial
- The P-II (DESTINY-Lung02) trial assessed Enhertu (5.4mg/kg & 6.4mg/kg) to treat NSCLC patients (n=152) across Asia, EU, Oceania & North America. Patients on 5.4mg/kg from Japan, Korea & Taiwan (China) showed confirmed ORR: 49%, mDoR: 16.8mos., mPFS: 9.9mos. & mOS: 19.5mos.
- The P-II (DESTINY-Lung05) study of Enhertu (5.4mg/kg) in Chinese patients (n=72) with HER2-mutated NSCLC showed a confirmed ORR of 58.3%
Ref: AstraZeneca | Image: Daiichi Sankyo & AstraZeneca
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
