Daiichi Sankyo’s Enhertu Receives the MHLW’s Approval as First HER2 Directed Therapy for HER2 Mutant Metastatic Non-Small Cell Lung Cancer
Shots:
- The MHLW has approved Enhertu for adult patients with unresectable advanced or recurrent NSCLC with HER2 (ERBB2) mutations that have progressed after CT. The approval was based on the P-II trial (DESTINY-Lung02) evaluating Enhertu (5.4 or 6.4mg/kg, q3w) in a ratio (2:1) in 151 patients at multiple sites, incl. Asia, Europe, Oceania & North America
- In a pre-specified interim analysis, Enhertu (5.4 & 6.4mg/kg) showed ORR (53.8% & 42.9%); CR (1.9% & 3.6%); PR (51.9% & 39.3%); m-DoR (not reached & 5.9mos.). The safety profile was consistent with prior trials with no new safety concerns, TRAEs (92.1%) in 5.4 mg/kg
- The results were presented at ESMO 2022. Enhertu (6.4mg/kg) was approved in 30+ countries for adult patients with LA or metastatic HER2+ gastric or GEJ adenocarcinoma
Ref: Daiichi Sankyo | Image: Daiichi Sankyo
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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.
