KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

Microsatellite instability-high cancer

Colorectal

KEYTRUDA® (powder for injection) is now also indicated in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication was approved via the provisional approval pathway, based on objective response rate and response duration in single-arm trials. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

Non-colorectal

KEYTRUDA® (powder for injection) is now also indicated in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours that have progressed following prior treatment and when there are 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. Sample sizes for individual tissue types were too small to provide data on clinical utility of the MSIH/ dMMR tests for each of the tissue types, individually. The assumption that MSI-H/dMMR status is predictive of the treatment effect of Keytruda for every tissue type has not been verified. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

The safety and effectiveness of KEYTRUDA in paediatric patients with MSI-H central nervous system cancers have not been established.