KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
124 working days (255)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
KEYTRUDA (powder for injection), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is now also indicated for the first-line treatment of patients with metastatic squamous NSCLC.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available