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AstraZeneca and Daiichi Sankyo Receive the EMA’s CHMP Positive Opinion Recommending Approval of Enhertu for HER2-Mutant Advanced NSCLC

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AstraZeneca and Daiichi Sankyo Receive the EMA’s CHMP Positive Opinion Recommending Approval of Enhertu for HER2-Mutant Advanced NSCLC

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  • 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

Related News:- Guardant Health Receives MHLW Approval for Guardant360 CDx as Companion Diagnostic to Enhertu for Non-Small Cell Lung Cancer

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Neha

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.

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