{"entity":{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","aka":[],"tldr":"Pembrolizumab is a PD-1 blocking antibody approved in more than 40 settings, from melanoma and lung cancer to the first tumour-agnostic approval for mismatch-repair-deficient tumours in 2017, and before and after surgery in triple-negative breast cancer. A subcutaneous form arrived in 2025, and it is the backbone partner for ADCs and personalised neoantigen vaccines.","summary":"Approvals span melanoma, NSCLC, head and neck, Hodgkin, urothelial, MSI-H/dMMR tumours (first tumour-agnostic approval, 2017), gastric, oesophageal, cervical, HCC, RCC, endometrial, TNBC (KEYNOTE-355 metastatic CPS ≥10; KEYNOTE-522 neoadjuvant/adjuvant with 7-year OS benefit), TMB-high, and more. 2026 additions include platinum-resistant PD-L1+ ovarian cancer, adjuvant RCC with belzutifan, and combination labels with sacituzumab govitecan (ASCENT-04) and enfortumab vedotin. Subcutaneous Keytruda Qlex approved 2025. Backbone for neoantigen vaccines (intismeran).","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Pembrolizumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Pembrolizumab"},{"label":"NICE TA851: pembrolizumab for neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer (14 December 2022)","url":"https://www.nice.org.uk/guidance/ta851"},{"label":"NICE TA801: pembrolizumab plus chemotherapy for untreated triple-negative metastatic breast cancer (29 June 2022)","url":"https://www.nice.org.uk/guidance/ta801"},{"label":"Keytruda label (openFDA): TNBC indications and KEYNOTE-522, KEYNOTE-355 and KEYNOTE-D19 study sections","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22KEYTRUDA%22"},{"label":"NICE TA914 (20 September 2023)","url":"https://www.nice.org.uk/guidance/ta914"},{"label":"NICE TA709: pembrolizumab for untreated MSI-high or dMMR metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta709"},{"label":"NICE TA531: pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta531"},{"label":"NICE TA683: pembrolizumab with pemetrexed and platinum chemotherapy for untreated metastatic non-squamous non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta683"},{"label":"NICE TA770: pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta770"},{"label":"NICE TA1017: pembrolizumab neoadjuvant then adjuvant for resectable non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1017"},{"label":"NICE TA1037: pembrolizumab for adjuvant treatment of resected non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1037"}],"tags":[],"related":["tmb-testing","pd-l1-cps","pd-l1-tps","dmmr-ihc","msi-high","tmb-high"],"cancers":["msi-high-pdac","tnbc","nsclc","melanoma","head-and-neck","recurrent-metastatic-hnscc","hpv-negative-head-and-neck-cancer","urothelial","colorectal","gastric","gastric-pdl1-high","gastric-msi-high","cervical","hcc","rcc","endometrial","hodgkin-lymphoma","ovarian","pancreatic","msi-high-colorectal","primary-mediastinal-b-cell-lymphoma","tnbc-early","tnbc-metastatic","pdl1-high-nsclc","resectable-nsclc","advanced-melanoma","stage-iii-melanoma","stage-ii-melanoma","advanced-cutaneous-scc","merkel-cell-carcinoma","endometrial-mmr-deficient","advanced-recurrent-endometrial-cancer","locally-advanced-cervical-cancer","recurrent-metastatic-cervical-cancer","platinum-resistant-ovarian-cancer","vaginal-adenocarcinoma","advanced-small-bowel-adenocarcinoma","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-522","keynote-355","ascent-04","interpath-001","nct06212752","nct06348199","nct06758401","nct06216301","nct05920356","nct06430866","nct06692738","nct06448312","nct06899126","nct06698042","nct07216703","nct06699212","nct05727904","nct04613596","nct07541170","nct07361510","nct06170788","nct06452277","nct06311721","nct06989112","nct06422143","nct05215340","nct05317858","nct06711900","nct06712316","nct06312137","nct05608291","nct06947928","nct06952504","nct05555732","nct06077760","nct06726265","nct02362594","nct06561386","nct04624204","nct06767514","nct05722015","nct06793215","nct06357533","nct05048797","nct06627647","nct05549297","nct04657991","nct04956692","nct05984277","nct07777822","nct07178795","nct07195695","nct05987332","nct03556228","nct05180799","nct05446298","nct05784688","nct03970746","nct02332668","nct05482893","nct04140526","nct04083599","nct07054567","nct03228667","nct03407144","nct06099782","nct07098988","nct06797297","nct05970497","keynote-158","nct03611868","nct04752826","nct04895722","nct05081609","nct06731907","nct06784648","nct05789082","nct06699836","nct06284590","nct05320588","nct07255664","nct05086692","nct04701476","nct07807163","nct03897881","nct05797168","nct04585750","nct06644768","nct03785249","nct07452224","nct06265025","nct07221474","nct05585320","nct04787042","nct04920617","nct05620134","nct07622186","nct04675294","nct05440708","nct05877430","nct06162221","nct03526835","nct07264816","nct04736173","nct05144698","nct02861573","nct05394103","nct03647163","nct05805501","nct05318573","nct05816252","nct07287917","nct06307431","nct06961006","nct06228326","nct06205706","nct07122687","nct07020221","nct06137144","nct03836352","nct05128487","nct05217446","nct06843447","nct04675333","nct05438420","nct05824975","nct06047379","nct05186974","nct05903833","nct04198766","nct04977453","nct03476681","nct05309421","nct06428409","nct05117242","nct07223047","nct04130516","nct06483334","nct05120596","nct04956640","nct06393374","nct07486817","nct07158918","nct05565378","nct05609578","nct06623422","nct07815665","nct06293651","nct04305795","nct03725059","nct06795412","nct06731478","nct06246110","nct07197827","nct07720284","nct07276399","nct06469944","nct07232602","nct07415031","nct06901531","nct06249048","nct06942234","nct07475806","nct07710885","nct05224141","nct04626479","nct07252739","nct06157151","nct03547973","nct06312176","nct06764875","nct05405595","nct07302347","nct06008093","nct04585035","nct07469774","nct05687266","nct06151574","nct04262466","nct04521413","nct05945823","nct05329532","nct06119581","nct06966700","nct04121455","nct06305767","nct06116136","nct05562830","nct07566156","nct06797635","nct06877650","nct03485209","nct05642780","nct05609968","nct06385080","nct06549946","nct07644039","nct06545955","nct03505320","nct05319730","nct06772623","nct06041802","nct04225117","nct05732831","nct05669430","nct04241185","nct05899049","nct04938817","nct05101070","nct04976634","nct04895358","nct04626518","nct06112379","nct07315750","nct05761223","nct07679360","nct07639450","nct05173987","nct04041310","nct06875310","nct06016920","nct06780111","nct05911295","nct05410145","nct06225596","nct07751042","nct05533697","nct06868277","nct05438329","nct06978114","nct06788912","nct03711032","nct05852691","nct07730021","nct06962787","nct06618287","nct07811193","nct06472076","nct07287995","nct04561362","nct05239741","nct06493552","nct04879329","nct05053880","nct06556563","nct06939595","nct05845814","nct04380636","nct07286266","nct06841354","nct07749586","nct04592653","nct04634877","nct06890598","nct06634875","keynote-119","swog-s1418","neopact","c-trak-tn","impassion030","nct05093231","keynote-091","keynote-671","keynote-024-189","keynote-042","keynote-407"],"people":["tasuku-honjo","lajos-pusztai"],"bottlenecks":[],"keyPapers":["paper-keynote-189-nejm-2018","paper-keynote-564-nejm-2021","paper-keynote-355-nejm-2022","paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023","paper-keynote-158-pembrolizumab-msi-high-noncolorectal-jco-2020","paper-hu-mismatch-repair-deficiency-pancreatic-adenocarcinoma-ccr-2018","paper-le-mmr-deficiency-pd1-nejm-2015","paper-le-mmr-deficiency-science-2017","paper-moreira-lynch-syndrome-identification-jama-2012"],"journals":[],"dependsOn":[],"notes":["Triple-negative breast cancer: metastatic use requires 22C3 CPS 10 or more, about 27% of unselected early tumours and 38% of KEYNOTE-355 screening (Cortes 2022, Sigurjonsdottir 2023); early-stage use in KEYNOTE-522 needs no PD-L1 test.","Triple-negative breast cancer, UK status: two NICE appraisals are in force (TA851 early disease, TA801 metastatic CPS 10 or more with immune-cell staining below 1 percent). A third, pembrolizumab as adjuvant treatment after neoadjuvant chemotherapy alone (GID-TA11724, the SWOG S1418 question), is awaiting development, and the appraisal of pembrolizumab for previously treated metastatic disease (GID-TA10295, KEYNOTE-119) was discontinued after that trial missed its primary endpoint.","Pancreatic cancer: the Keytruda label's tumour-agnostic MSI-H or dMMR indication rests on KEYNOTE-158, whose pancreatic cohort had 4 responses in 22 patients (18 percent; 95 percent confidence interval 5 to 40; duration 8.1 to 24.3 or more months). In the EU the MSI-H indication names colorectal, endometrial, gastric, small intestine and biliary cancer and in England NICE TA914 mirrors that list, so mismatch repair deficient pancreatic cancer (about 1 percent of cases) has no funded checkpoint inhibitor route in Europe outside trials such as the Cambridge-led pembrolizumab and olaparib study (NCT05093231, 15 UK sites).","Pancreatic ductal adenocarcinoma: the threshold is MSI-high or mismatch repair deficiency, about 1% of cases; KEYNOTE-158's pancreatic cohort gave 4 responses among 22 patients against 34.3% across all non-colorectal MSI-high tumours (Marabelle 2020). PD-L1 expression is not a threshold in this disease and unselected checkpoint blockade has failed.","Colorectal cancer biomarkers: MSI-high or mismatch repair deficiency, about 5% of metastatic and 10 to 15% of resected disease. The first study gave 4 responses in 10 deficient colorectal cancers and 0 in 18 proficient ones (Le 2015). PD-L1 expression and tumour mutational burden are not colorectal thresholds; universal mismatch repair testing identifies the eligible patients as a by-product of Lynch syndrome screening (Moreira 2012)."],"brand":"Keytruda / Keytruda Qlex (SC)","modality":"Monoclonal antibody (anti-PD-1)","mechanism":"Humanised IgG4 blocking PD-1; restores T-cell effector function.","approvals":[{"region":"US","year":2014,"indication":"Melanoma (first of >40 indications)"},{"region":"US","year":2017,"indication":"MSI-H/dMMR solid tumours (tumour-agnostic)"},{"region":"US","year":2020,"indication":"Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy"},{"region":"US","year":2021,"indication":"High-risk early TNBC, neoadjuvant + adjuvant (KEYNOTE-522)"},{"region":"US","year":2023,"indication":"Locally advanced unresectable or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (KEYNOTE-966)","note":"Keytruda label (openFDA), KEYNOTE-966 section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22KEYTRUDA%22; no NICE appraisal for biliary tract cancer found in September 2026"},{"region":"US","year":2026,"indication":"Platinum-resistant PD-L1+ ovarian cancer; adjuvant RCC with belzutifan; with sacituzumab govitecan in 1L TNBC"},{"region":"EU","year":2021,"indication":"Locally recurrent unresectable or metastatic TNBC, PD-L1 CPS 10 or more, with chemotherapy, no prior chemotherapy for metastatic disease (KEYNOTE-355)","note":"EMA Keytruda product page, therapeutic indications: https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda"},{"region":"EU","year":2022,"indication":"Locally advanced or early-stage TNBC at high risk of recurrence: neoadjuvant with chemotherapy, then adjuvant monotherapy (KEYNOTE-522)","note":"EMA Keytruda product page: https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda"},{"region":"UK","year":2022,"indication":"Untreated triple-negative locally recurrent unresectable or metastatic breast cancer with paclitaxel or nab-paclitaxel; NICE TA801 (29 June 2022) recommends it only for tumours with CPS 10 or more and immune-cell staining below 1 percent (the atezolizumab population is carved out), under a commercial arrangement","note":"https://www.nice.org.uk/guidance/ta801"},{"region":"UK","year":2022,"indication":"Neoadjuvant with chemotherapy then adjuvant alone for triple-negative early breast cancer at high risk of recurrence or locally advanced disease; NICE TA851 (14 December 2022) recommends within the marketing authorisation, routine commissioning with a commercial arrangement","note":"https://www.nice.org.uk/guidance/ta851"},{"region":"UK","year":2023,"indication":"Mismatch repair deficient or MSI-high tumours: NICE TA914 (20 September 2023) covers previously treated endometrial, gastric, small intestine, biliary and colorectal cancer and does not include pancreatic cancer","note":"https://www.nice.org.uk/guidance/ta914"},{"region":"England (NICE)","year":2021,"indication":"Untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency","note":"TA709, published 23 June 2021: recommended only if pembrolizumab is stopped after two years without documented progression and the company provides it under the commercial arrangement."},{"region":"England (NICE)","year":2023,"indication":"Previously treated MSI-high or dMMR endometrial, biliary, colorectal, gastric or small intestine cancer","note":"TA914, published 20 September 2023: in colorectal cancer after fluoropyrimidine combination therapy, only if nivolumab with ipilimumab is unsuitable, and stopped at two years."},{"region":"England (NICE)","year":2018,"indication":"Untreated PD-L1-positive metastatic non-small-cell lung cancer with a tumour proportion score of 50 percent or more and no EGFR or ALK alteration","note":"TA531, published 18 July 2018, only if pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier on progression."},{"region":"England (NICE)","year":2021,"indication":"Untreated metastatic non-squamous non-small-cell lung cancer without an EGFR or ALK alteration, with pemetrexed and platinum chemotherapy","note":"TA683, published 10 March 2021, only if stopped at 2 years of uninterrupted treatment or earlier on progression."},{"region":"England (NICE)","year":2022,"indication":"Untreated metastatic squamous non-small-cell lung cancer, with carboplatin and paclitaxel","note":"TA770, published 9 February 2022, for a tumour proportion score of 0 to 49 percent, or 50 percent or more where urgent clinical intervention is needed, stopped at 2 years."},{"region":"England (NICE)","year":2017,"indication":"Locally advanced or metastatic PD-L1-positive non-small-cell lung cancer after at least one chemotherapy","note":"TA428, published 11 January 2017 and last updated 12 September 2017, stopped at 2 years of uninterrupted treatment."},{"region":"England (NICE)","year":2024,"indication":"Resectable non-small-cell lung cancer at high risk of recurrence, neoadjuvant with platinum chemotherapy then adjuvant alone","note":"TA1017, published 20 November 2024 (KEYNOTE-671), subject to the commercial arrangement."},{"region":"England (NICE)","year":2025,"indication":"Adjuvant treatment of non-small-cell lung cancer at high risk of recurrence after complete resection and platinum chemotherapy","note":"TA1037, published 5 February 2025 (KEYNOTE-091), subject to the commercial arrangement."}],"mechanismSteps":["Antibody binds PD-1 on T cells","PD-1/PD-L1 engagement between T cell and tumour is blocked","Exhausted tumour-reactive T cells regain effector function","Interferon-γ and cytotoxic granules are released at the tumour","Tumour cells are killed; memory T cells persist"],"dosing":{"route":"IV infusion over 30 min (subcutaneous Keytruda Qlex available)","schedule":"200 mg every 3 weeks or 400 mg every 6 weeks; paediatric 2 mg/kg (max 200 mg) every 3 weeks; up to 24 months in most metastatic settings","modifications":"Hold for grade 2 immune-mediated events; permanently discontinue for grade 4 or recurrent grade 3","monitoring":"Thyroid function, LFTs, creatinine, glucose at baseline and periodically; patient education on immune-related symptoms","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287"},"toxicity":[{"event":"Hypothyroidism (immune-mediated)","anyGradePct":8,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Pneumonitis (immune-mediated)","anyGradePct":3.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Colitis (immune-mediated)","anyGradePct":1.7,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Hepatitis (immune-mediated)","anyGradePct":0.7,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Fatigue","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Musculoskeletal pain","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Rash","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Diarrhoea","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"},{"event":"Pyrexia","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","note":"Pooled monotherapy data, >2,800 patients"}],"access":[{"country":"US","listPrice":"$11,564 per 200 mg dose (WAC, Merck price disclosure 2024)","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.merckaccessprogram-keytruda.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended across many indications (melanoma, NSCLC, TNBC KEYNOTE-522/355, RCC, HNSCC, cervical, oesophageal and others)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"},{"country":"EU","reimbursement":"EMA approved; reimbursed in all member states for core indications","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2014-09-04","type":"accelerated-approval","region":"US","note":"Accelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor"},{"date":"2015-10-02","type":"accelerated-approval","region":"US","note":"PD-L1+ NSCLC after platinum","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy"},{"date":"2015-12-18","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2014 converted to traditional approval 1.3 years after it was granted.","indication":"Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor"},{"date":"2016-08-05","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy"},{"date":"2016-10-24","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2015 converted to traditional approval 1.1 years after it was granted.","indication":"Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy"},{"date":"2017-03-14","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapy"},{"date":"2017-05-10","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC"},{"date":"2017-05-18","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov#footnote1_815g9a4","indication":"Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 1"},{"date":"2017-05-23","type":"accelerated-approval","region":"US","note":"MSI-H/dMMR solid tumours: first tumour-agnostic approval","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"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 treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan"},{"date":"2017-09-22","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapy"},{"date":"2018-06-12","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"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"},{"date":"2018-06-13","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy"},{"date":"2018-08-20","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2017 converted to traditional approval 1.3 years after it was granted.","indication":"In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC"},{"date":"2018-11-09","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov/drugs/fda-grants-accelerated-approval-pembrolizumab-hepatocellular-carcinoma","indication":"Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib"},{"date":"2018-12-19","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov/drugs/fda-approves-pembrolizumab-merkel-cell-carcinoma","indication":"Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)"},{"date":"2019-06-10","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2016 converted to traditional approval 2.8 years after it was granted.","indication":"Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy"},{"date":"2019-06-17","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy"},{"date":"2019-09-17","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation"},{"date":"2020-04-28","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with melanoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, cervical carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, small cell lung cancer, esophageal cancer, microsatellite instability-high or mismatch repair deficient solid tumors"},{"date":"2020-04-28","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.4 years later, when the FDA's table was read.","indication":"Dosing Regimen: Alternative dose/schedule of 400 mg every 6 weeks for adult patients with classical Hodgkin lymphoma and primary mediastinal b-cell lymphoma"},{"date":"2020-06-16","type":"accelerated-approval","region":"US","note":"TMB-high solid tumours (tumour-agnostic) The confirmatory requirement was still open 6.3 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"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, that have progressed following prior treatment and who have no satisfactory alternative treatment options ."},{"date":"2020-06-16","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Dosing Regimen: Alternate Dose/Schedule of 400 mg every 6 weeks for adult patients with unresectable or metastatic tumor mutational burden high [≥10 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with a confirmatory trial required.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pembrolizumab-her2-positive-gastric-cancer","indication":"In combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma 1"},{"date":"2021-07-21","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2019 converted to traditional approval 1.8 years after it was granted.","indication":"In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation"},{"date":"2021-07-26","type":"conversion","region":"US","note":"High-risk early TNBC, neoadjuvant and adjuvant 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>/=1) as determined by an FDA approved test"},{"date":"2022-02-04","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 4.4 years after its accelerated approval.","indication":"For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapy"},{"date":"2022-12-16","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2020 converted to traditional approval 2.6 years after it was granted.","indication":"Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with melanoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, cervical 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enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy"},{"date":"2023-10-12","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2018 converted to traditional approval 4.8 years after it was granted.","source":"https://www.fda.gov/drugs/fda-approves-pembrolizumab-merkel-cell-carcinoma","indication":"Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)"},{"date":"2023-10-16","type":"approval","region":"US","note":"Perioperative NSCLC (KEYNOTE-671)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-12-15","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2023 converted to traditional approval 0.7 years after it was 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(LITESPARK-022)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma"},{"date":"2026-06-24","type":"approval","region":"US","note":"First-line PD-L1+ TNBC with sacituzumab govitecan (ASCENT-04)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"date":"2026-07-10","type":"approval","region":"US","note":"Muscle-invasive bladder cancer with enfortumab vedotin, as pembrolizumab or pembrolizumab with berahyaluronidase alfa","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin"}]},"route":"/drugs/pembrolizumab/","neighbours":{"technology":[{"id":"cannabinoids-pain-appetite","kind":"technology","name":"Cannabis and cannabinoids for pain, appetite and cancer 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