KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
149 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Oesophageal Cancer
KEYTRUDA (pembrolizumab) (concentrated injection and powder for injection), in combination with platinum and fluoropyrimidine based chemotherapy, is now also indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.
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.