Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع البتراء للمواد الطبية - petra drug store - axitinib 1 mg - 1 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع البتراء للمواد الطبية - petra drug store - axitinib 5 mg - 5 mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

pfizer pharmaceuticals inc. - axitinib - red tablet, major axis: 8.6 mm, minor axis: 4.3 mm, thickness: 2.8 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

pfizer pharmaceuticals inc. - axitinib - red tablet, major axis: 7.7 mm, thickness: 3.8 mm

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sdn. bhd. - avelumab -

United States - English - NLM (National Library of Medicine)

emd serono, inc. - avelumab (unii: kxg2pj551i) (avelumab - unii:kxg2pj551i) - avelumab 20 mg in 1 ml - bavencio (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic merkel cell carcinoma (mcc). first-line maintenance treatment of urothelial carcinoma bavencio is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (uc) that has not progressed with first-line platinum-containing chemotherapy [see clinical studies (14.2)] . previously-treated urothelial carcinoma bavencio is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (uc) who: - have disease progression during or following platinum-containing chemotherapy - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy [see clinical studies (14.2)]. bavencio in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc) [see clinical studies (14.3)] . none. risk summary based on its mechanism of action, bavencio can cause fetal harm when administered to a pregnant woman. there are no available data on the use of bavencio in pregnant women [see clinical pharmacology (12.1)] . animal studies have demonstrated that inhibition of the pd-1/pd-l1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death [see data] . human igg1 immunoglobulins (igg1) are known to cross the placenta. therefore, bavencio has the potential to be transmitted from the mother to the developing fetus. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data animal reproduction studies have not been conducted with bavencio to evaluate its effect on reproduction and fetal development. a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. in murine models of pregnancy, blockade of pd-l1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering bavencio during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1/pd-l1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 and pd-l1 knockout mice. based on its mechanism of action, fetal exposure to bavencio may increase the risk of developing immune-related disorders or altering the normal immune response. risk summary there is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production. since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of bavencio due to the potential for serious adverse reactions in breastfed infants. contraception based on its mechanism of action, bavencio can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with bavencio and for at least 1 month after the last dose of bavencio. the safety and effectiveness of bavencio have been established in pediatric patients aged 12 years and older for metastatic mcc. use of bavencio in this age group is supported by evidence from adequate and well-controlled studies of bavencio in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the steady state exposure of avelumab, that drug exposure is generally similar between adults and pediatric patients age 12 years and older for monoclonal antibodies, and that the course of mcc is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients. the recommended dose in pediatric patients 12 years of age or greater is the same as that in adults [see dosage and administration (2.2), clinical pharmacology (12.3), and clinical studies (14)] . safety and effectiveness of bavencio have not been established in pediatric patients less than 12 years of age. metastatic merkel cell carcinoma of the 204 patients with mcc who received bavencio in the javelin merkel 200 trial, 78% were 65 years or older and 43% were 75 years or older. no overall differences in safety or efficacy were observed between elderly patients and younger patients. locally advanced or metastatic urothelial carcinoma of the 344 patients randomized to bavencio 10 mg/kg plus bsc in the javelin bladder 100 trial, 63% were 65 years or older and 24% were 75 years or older. no overall differences in safety or efficacy were reported between elderly patients and younger patients. advanced renal cell carcinoma of the 434 patients randomized to bavencio 10 mg/kg administered in combination with axitinib 5 mg twice daily in the javelin renal 101 trial, 38% were 65 years or older and 8% were 75 years or older. no overall difference in safety or efficacy were reported between elderly patients and younger patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - avelumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: polysorbate 20; mannitol; glacial acetic acid; sodium hydroxide; water for injections - bavencio is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic merkel cell carcinoma (mmcc). this indication is approved based on tumour response rate, duration of response in a single arm study.,bavencio is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (uc) whose disease has not progressed with first-line platinum-based induction chemotherapy.,bavencio in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc).

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - pembrolizumab - concentrate for solution for infusion - pembrolizumab 25 mg/ml - pembrolizumab - melanoma• keytruda is indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma.•keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage iib, iic, or iii melanoma following complete resection.non-small cell lung cancer• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound , is indicated for the first-line treatment of patients with metastatic squamous nsclc.• keytruda, as a single agent, is indicated for the treatment of patients with metastatic nsclc whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda .• keytruda, as a single agent, is indicated for the treatment of patients with advanced nsclc whose tumors express pd-l1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving keytruda .• keytruda , as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc.head and neck cancer• keytruda, in combination with platinum and fluorouracil (fu), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (hnscc).• keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent hnscc whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test .• keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic hnscc with disease progression on or after platinum-containing chemotherapy..classical hodgkin lymphoma• keytruda is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (chl).• keytruda is indicated for the treatment of pediatric patients with refractory chl, or chl that has relapsed after 2 or more lines of therapyprimary mediastinal large b-cell lymphoma keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy.limitation of use: keytruda is not recommended for treatment of patients with pmbcl who require urgent cytoreductive therapy.urothelial carcinoma• keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors 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. • keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.microsatellite instability-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (msi h) or mismatch repair deficient (dmmr). • solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options,or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.limitation of use: the safety and effectiveness of keytruda in pediatric patients with msi h central nervous system cancers have not been established. gastric cancer• keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction (gej) adenocarcinoma in adults whose tumors express pd-l1 with a cps ≥ 1.• keytruda ,as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gej whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, her2/neu targeted therapy.cervical cancer• keytruda, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express pd-l1 (cps ≥1) as determined by a validated test. • keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express pd-l1 (cps ≥1) as determined by a validated test.biliary tract carcinomakeytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (btc).merkel cell carcinomakeytruda is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic merkel cell carcinoma (mcc).renal cell carcinoma• keytruda, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).• keytruda, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced rcc.• keytruda is indicated for the adjuvant treatment of patients with rcc at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.non-muscle invasive bladder cancer (nmibc)keytruda 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 tumors who are ineligible for or have elected not to undergo cystectomy.esophageal cancer• keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (gej) (siewert type i) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.• keytruda is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express pd-l1 (cps ≥10) as determined by a validated test, with disease progression after one or more prior lines of systemic therapy.cutaneous squamous cell carcinomakeytruda is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiationmicrosatellite instability-high or mismatch repair deficient colorectal cancer (crc)keytruda is indicated for the first-line treatment of patients with unresectable or metastatic msi-h or dmmr colorectal cancer (crc).tumor mutational burden-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (tmb-h) [≥10 mutations/megabase (mut/mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.limitations of use: the safety and effectiveness of keytruda in pediatric patients with tmb-h central nervous system cancers have not been established.triple negative breast cancer• keytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (tnbc) whose tumors express pd-l1 (cps ≥10) as determined by a validated test• keytruda 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 a single agent as adjuvant treatment after surgery.endometrial carcinomakeytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - pembrolizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - 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 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 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 4 cm), ii, or iiia nsclc who have undergone complete resection and platinum-based chemotherapy.,head and neck squamous cell cancer (hnscc),,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 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 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) 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.,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 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 1] as determined by a validated test.,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).,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 adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) 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 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.,cutaneous squamous cell carcinoma,,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.,this indication was approved via the provisional approval pathway based on objective response rate and duration of response from a single-arm study. improvements in overall survival, progression-free survival, or healthrelated quality of life have not been established. full registration for this indication depends on submission of further clinical data to confirm the clinical benefit of the medicine.,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 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. 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.

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - pembrolizumab (unii: dpt0o3t46p) (pembrolizumab - unii:dpt0o3t46p) - pembrolizumab 50 mg in 2 ml - keytruda® is indicated for the treatment of patients with unresectable or metastatic melanoma. keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage iib, iic, or iii melanoma following complete resection. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. keytruda, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous nsclc. keytruda, as a single agent, is indicated for the first-line treatment of patients with nsclc expressing pd-l1 [tumor proportion score (tps) ≥1%] as determined by an fda-approved test [see dosage and administration (2.1)] , with no egfr or alk genomic tumor aberrations, and is: - stage iii where patients are not candidates for surgical resection or definitive chemoradiation, or - metastatic. keytruda, as a single agent, is indicated for the treatment of patients with metastatic nsclc whose tumors express pd-l1 (tps ≥1%) as determined by an fda-approved test [see dosage and administration (2.1)] , with disease progression on or after platinum-containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on fda-approved therapy for these aberrations prior to receiving keytruda. keytruda is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) nsclc in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. keytruda, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc. keytruda, in combination with platinum and fluorouracil (fu), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (hnscc). keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent hnscc whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic hnscc with disease progression on or after platinum-containing chemotherapy. keytruda is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (chl). keytruda is indicated for the treatment of pediatric patients with refractory chl, or chl that has relapsed after 2 or more lines of therapy. keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy. limitations of use : keytruda is not recommended for treatment of patients with pmbcl who require urgent cytoreductive therapy. keytruda, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. keytruda, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: - who are not eligible for any platinum-containing chemotherapy, or - who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. keytruda, as a single agent, 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 tumors who are ineligible for or have elected not to undergo cystectomy. keytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) solid tumors, as determined by an fda-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see dosage and administration (2.1)] . keytruda is indicated for the treatment of patients with unresectable or metastatic msi-h or dmmr colorectal cancer (crc) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma whose tumors express pd-l1 (cps ≥1) as determined by an fda-approved test [see dosage and administration (2.1)] . this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies (14.9)] . continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. keytruda, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic her2-negative gastric or gastroesophageal junction (gej) adenocarcinoma. keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (gej) (tumors with epicenter 1 to 5 centimeters above the gej) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: - in combination with platinum- and fluoropyrimidine-based chemotherapy, or - as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express pd-l1 (cps ≥10) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda, in combination with chemoradiotherapy (crt), is indicated for the treatment of patients with figo 2014 stage iii-iva cervical cancer. keytruda, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express pd-l1 (cps ≥1) as determined by an fda-approved test [see dosage and administration (2.1)]. keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express pd-l1 (cps ≥1) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda is indicated for the treatment of patients with hepatocellular carcinoma (hcc) secondary to hepatitis b who have received prior systemic therapy other than a pd-1/pd-l1-containing regimen. keytruda, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (btc). keytruda is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic merkel cell carcinoma (mcc). keytruda, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc). keytruda, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced rcc. keytruda is indicated for the adjuvant treatment of patients with rcc at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see clinical studies (14.15)] . keytruda, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pmmr) as determined by an fda-approved test or not msi-h, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see dosage and administration (2.1)] . keytruda, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is msi-h or dmmr, as determined by an fda-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see dosage and administration (2.1)] . keytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (tmb-h) [≥10 mutations/megabase (mut/mb)] solid tumors, as determined by an fda-approved test [see dosage and administration (2.1)] , that have progressed following prior treatment and who have no satisfactory alternative treatment options. this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies (14.17)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. limitations of use : the safety and effectiveness of keytruda in pediatric patients with tmb-h central nervous system cancers have not been established. keytruda is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiation. keytruda 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 a single agent as adjuvant treatment after surgery. keytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic tnbc whose tumors express pd-l1 (cps ≥10) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for classical hodgkin lymphoma and primary mediastinal large b-cell lymphoma in adults [see indications and usage (1.4, 1.5), dosage and administration (2.2)] . this indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety [see clinical pharmacology (12.2), clinical studies (14.20)] . continued approval for this dosage may be contingent upon verification and description of clinical benefit in the confirmatory trials. none. risk summary based on its mechanism of action, keytruda can cause fetal harm when administered to a pregnant woman. there are no available human data informing the risk of embryo-fetal toxicity. in animal models, the pd-1/pd-l1 signaling pathway is important in the maintenance of pregnancy through induction of maternal immune tolerance to fetal tissue (see data) . human igg4 (immunoglobulins) are known to cross the placenta; therefore, pembrolizumab has the potential to be transmitted from the mother to the developing fetus. advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data animal reproduction studies have not been conducted with keytruda to evaluate its effect on reproduction and fetal development. a literature-based assessment of the effects of the pd-1 pathway on reproduction demonstrated that a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. blockade of pd-l1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering keytruda during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 knockout mice. based on its mechanism of action, fetal exposure to pembrolizumab may increase the risk of developing immune-mediated disorders or of altering the normal immune response. risk summary there are no data on the presence of pembrolizumab in either animal or human milk or its effects on the breastfed child or on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to keytruda are unknown. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with keytruda and for 4 months after the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating keytruda [see use in specific populations (8.1)]. contraception keytruda can cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.5), use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with keytruda and for 4 months after the last dose. the safety and effectiveness of keytruda as a single agent have been established in pediatric patients with melanoma, chl, pmbcl, mcc, msi-h or dmmr cancer, and tmb-h cancer. use of keytruda in pediatric patients for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1, 14.4, 14.5, 14.7, 14.14, 14.17)] . in keynote-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 to 17 years) with advanced melanoma, lymphoma, or pd-l1 positive solid tumors received keytruda 2 mg/kg every 3 weeks. the median duration of exposure was 2.1 months (range: 1 day to 25 months). adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults included pyrexia (33%), vomiting (29%), headache (25%), abdominal pain (23%), decreased lymphocyte count (13%), and decreased white blood cell count (11%). laboratory abnormalities that occurred at a ≥10% higher rate in pediatric patients when compared to adults were leukopenia (31%), neutropenia (28%), thrombocytopenia (22%), and grade 3 anemia (17%). the safety and effectiveness of keytruda in pediatric patients have not been established in the other approved indications [see indications and usage (1)] . of 3781 patients with melanoma, nsclc, hnscc, or urothelial carcinoma who were treated with keytruda in clinical studies, 48% were 65 years and over and 17% were 75 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of 389 adult patients with chl who were treated with keytruda in clinical studies, 46 (12%) were 65 years and over. patients aged 65 years and over had a higher incidence of serious adverse reactions (50%) than patients aged younger than 65 years (24%). clinical studies of keytruda in chl did not include sufficient numbers of patients aged 65 years and over to determine whether effectiveness differs from that in younger patients. of 506 adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc following complete resection and platinum-based chemotherapy who were treated with keytruda in keynote-091, 242 (48%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of 596 adult patients with tnbc who were treated with keytruda in combination with paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin in keynote-355, 137 (23%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of 406 adult patients with endometrial carcinoma who were treated with keytruda in combination with lenvatinib in keynote-775, 201 (50%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of the 564 patients with locally advanced or metastatic urothelial cancer treated with keytruda in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. no overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. patients 75 years of age or older treated with keytruda in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. the incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. of the 432 patients randomized to keytruda in combination with axitinib in the keynote-426 trial, 40% were 65 years or older. no overall difference in safety or efficacy was reported between patients who were ≥65 years of age and younger. of 292 adult patients with figo 2014 stage iii-iva cervical cancer who were treated with keytruda in combination with crt in keynote-a18, 42 (14%) were 65 years and over. no overall differences in safety or efficacy were observed between elderly and younger patients.