Keytruda

What it is used for

Melanoma,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the adjuvant treatment ofpatients with melanoma with lymph node involvement who have undergone complete resection.,Non-small cell lung cancer (NSCLC),KEYTRUDA® (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumour aberrations.,KEYTRUDA® (pembrolizumab), in combination with carboplatin and either paclitaxel or nabpaclitaxel,is indicated for the first-line treatment of patients with metastatic squamous NSCLC.,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the first-line treatment of patients with NSCLC expressing PD-L1 [tumour proportion score (TPS) =1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and is,- stage III where patients are not candidates for surgical resection or definitive chemoradiation, or,- metastatic.,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with advanced NSCLC whose tumours express PD-L1 with a =1% TPS as determined by a validated test and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving KEYTRUDA.,Head and Neck Squamous Cell Cancer (HNSCC),KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival or health-related quality of life have not been established.,Classical Hodgkin Lymphoma (cHL),KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin Lymphoma (cHL):,1. following autologous stem cell transplant (ASCT) or,2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.,The approval of this indication is on the basis of objective response rate (ORR). See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials.,Primary mediastinal B-Cell Lymphoma (PMBCL),KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. The approval of this indication is on the basis of objective response rate (ORR) and duration of response from non-randomised studies. See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials.,Urothelial carcinoma,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin containing therapy and whose tumours express PD-L1 [Combined Positive Score (CPS) =10] as determined by a validated test, or in patients who are not eligible for any platinum containing chemotherapy regardless of PD-L1 status. This indication is approved based on overall response rate and duration of response in a single-arm study. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.,Microsatellite instability-high cancer,Colorectal,KEYTRUDA® (pembrolizumab) is indicated in adult and paediatric patients for the treatmentof 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® (pembrolizumab) is 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.,Endometrial carcinoma,KEYTRUDA® (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.