AstraZeneca and Daiichi Sankyo Receive the EMA’s CHMP Positive Opinion Recommending Approval of Enhertu for HER2-Mutant Advanced NSCLC
- The EMA’s CHMP has adopted the positive opinion recommending approval of Enhertu (5.4mg/kg) as monotx. for adult patients with advanced NSCLC whose tumors have an activating HER2 (ERBB2) mutation & require systemic therapy following Pt-based CT with/out immunotherapy
- The opinion was based on the P-II trial (DESTINY-Lung02) of Enhertu in a ratio (2:1) in 152 patients at multiple sites, incl. Asia, EU & North America, showed ORR (49.0%), DCR (93.1%), CR (1.0%), PR (48.0%), m-DoR (16.8mos.) & the results were presented at IASLC 2023 & published in the Journal of Clinical Oncology
- The safety profile was consistent with prior clinical trials with no new safety signals. Enhertu (5.4mg/kg) was approved in 50+ countries for unresectable or metastatic HER2+ breast cancer
Ref: AstraZeneca | Image: AstraZeneca
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