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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
182 working days (255)
Active ingredients
pembrolizumab (rch)
Registration type
EOI
Indication
KEYTRUDA is now also indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- are not eligible for cisplatin-containing therapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established; or
- have received platinum-containing chemotherapy