Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
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
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab
Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022
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