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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
201 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Tumour Mutational Burden-High (TMB-H) cancer
KEYTRUDA (pembrolizumab) (concentrated injection and powder for injection) is now also indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [≥10 mutations / megabase (mut/Mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication was approved via the provisional approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. The assumption that TMB-H status is predictive of the treatment effect of KEYTRUDA for every tissue type has not been verified. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration