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.
