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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
194 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Cutaneous Squamous Cell Carcinoma
KEYTRUDA (pembrolizumab) (powder for concentrated injection) is now also indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. This indication was approved via the provisional approval pathway based on objective response rate and duration of response from a single-arm study. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established. Full registration for this indication depends on submission of further clinical data to confirm the clinical benefit of the medicine.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration