KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
KEYTRUDA (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ge1] as determined by a validated test.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.