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( ARTG ) Melanoma,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.,KEYTRUDA® (pembrolizumab) is indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with Stage IIB, IIC, or III melanoma 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 non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations.,KEYTRUDA® (pembrolizumab), in combination with carboplatin and either paclitaxel or nab-paclitaxel, 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) greater than or equal to 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 greater than or equal to 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.,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the adjuvant treatment of patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.,KEYTRUDA® (pembrolizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of patients with resectable Stage II, IIIA, or IIIB (T3-4N2) NSCLC.,Malignant Pleural Mesothelioma,KEYTRUDA® (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).,Head and neck squamous cell cancer (HNSCC),KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumours express PD-L1 with a CPS greater than or equal to 1, as determined by a validated test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.,KEYTRUDA® (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by a validated test.,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by a validated test.,Classical Hodgkin lymphoma (cHL),KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of adult and paediatric 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 in paediatric patients is on the basis of objective response rate from patients aged 11 years and older from single arm trial data and extrapolation from adult data (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), in combination with enfortumab vedotin, is indicated for the first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC).,KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. 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 (MSI-H) or mismatch repair deficient (dMMR) cancer,KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are MSI-H or dMMR, as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options.,Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer,KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.,Biliary tract carcinoma (BTC),KEYTRUDA® (pembrolizumab), in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).,Endometrial carcinoma,KEYTRUDA® (pembrolizumab), in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent 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 in any setting and are not candidates for curative surgery or radiation.,Cervical cancer,KEYTRUDA® (pembrolizumab), in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with high-risk, locally advanced cervical cancer (FIGO 2014 Stage IB2-IIB and node-positive, or Stage III-IVA).,KEYTRUDA® (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by a validated test.,Merkel Cell Carcinoma (MCC),KEYTRUDA® (pembrolizumab), as monotherapy, is indicated for the treatment of adult and adolescent (12 years and older) patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).,Renal cell carcinoma (RCC),KEYTRUDA® (pembrolizumab), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).,KEYTRUDA® in combination with LENVIMA® (lenvatinib) is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).,KEYTRUDA® (pembrolizumab), as monotherapy, is indicated for the adjuvant treatment of patients with RCC with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (see section 5.1, Clinical Trials: Renal Cell Carcinoma).,Cutaneous squamous cell carcinoma (cSCC),KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.,Gastric cancer,KEYTRUDA® (pembrolizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GOJ) adenocarcinoma that is not HER2-positive.,KEYTRUDA® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GOJ) adenocarcinoma, whose tumours express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by a validated test.,Oesophageal cancer,KEYTRUDA® (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2-negative gastroesophageal junction (GOJ) adenocarcinoma (tumour centre 1 to 5 centimetres above the GOJ) that is not amenable to surgical resection or definitive chemoradiation.,Triple-negative breast cancer,KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.,KEYTRUDA® (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS greater than or equal to 10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.Urothelial carcinoma,KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy. This indication was approved via the provisional approval pathway based on complete response rate and duration of response. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.,Tumour mutational burden-high (TMB-H) cancer,KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [greater than or equal to 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.