KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
199 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Biliary Tract Carcinoma
KEYTRUDA® (pembrolizumab), in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.