Keytruda | Pembrolizumab (download only)

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Keytruda (pembrolizumab) is indicated for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) bowel cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

This indication was approved via the Therapeutic Goods Administration's (TGA) 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.

Is Keytruda available on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment?

  • In 2019, Keytruda received provisional-approval from the Therapeutic Goods Administration (TGA) for use in Australia as a treatment option for patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) bowel cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Continued approval will depend on verification and description of clinical benefit in the confirmatory trials.
  • Keytruda is not currently listed on the PBS as a subsidised treatment.

    Download the Consumer Medicine Information (CMI) for Keytruda.