Drug Approval | October 16, 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Impressive safety and efficacy for solid cancer patients followed by global clinical study plan
KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
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