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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
154 working days (255)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
KEYTRUDA (injection) is now also indicated for the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.