KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
168 working days (255)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is now also indicated for the first-line treatment of patients with metastatic non-squamous NSCLCs. This indication is approved based on tumour response rate and progression-free survival in a Phase-2 trial.