{"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"}],"tags":[],"related":[],"indications":["hcc","rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":2026,"indication":"Platinum-resistant PD-L1+ ovarian cancer; adjuvant RCC with belzutifan; with sacituzumab govitecan in 1L TNBC"}],"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":"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"},{"date":"2015-10-02","type":"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"},{"date":"2017-05-23","type":"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"},{"date":"2020-06-16","type":"approval","region":"US","note":"TMB-high solid tumours (tumour-agnostic)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-11-13","type":"approval","region":"US","note":"Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy (KEYNOTE-355)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2021-07-26","type":"approval","region":"US","note":"High-risk early TNBC, neoadjuvant and adjuvant (KEYNOTE-522)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"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":"2025-09","type":"approval","region":"US","note":"Subcutaneous pembrolizumab (Keytruda Qlex)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-Q1","type":"approval","region":"US","note":"Platinum-resistant PD-L1+ ovarian cancer","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-06-12","type":"approval","region":"US","note":"Adjuvant RCC with belzutifan (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":{"indication":[{"id":"hcc","kind":"indication","name":"Hepatocellular carcinoma","route":"/indications/hcc/"},{"id":"hcc-intermediate","kind":"indication","name":"Intermediate hepatocellular carcinoma (BCLC B)","route":"/indications/hcc-intermediate/"},{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"},{"id":"prostate-nepc","kind":"indication","name":"Neuroendocrine and small-cell prostate cancer","route":"/indications/prostate-nepc/"},{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/prostate/"},{"id":"rcc","kind":"indication","name":"Renal cell carcinoma","route":"/indications/rcc/"},{"id":"thyroid","kind":"indication","name":"Thyroid cancer","route":"/indications/thyroid/"}],"company":[{"id":"alpha-tau-medical","kind":"company","name":"Alpha Tau Medical","route":"/companies/alpha-tau-medical/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"institution":[{"id":"institut-jules-bordet","kind":"institution","name":"Institut Jules Bordet","route":"/institutions/institut-jules-bordet/"},{"id":"johns-hopkins","kind":"institution","name":"Johns Hopkins Hospital / Sidney Kimmel Comprehensive Cancer Center","route":"/institutions/johns-hopkins/"}],"drug":[{"id":"pb-212-psv359","kind":"drug","name":"Lead-212 PSV359","route":"/drugs/pb-212-psv359/"}],"idea":[{"id":"idea-rlt-plus-checkpoint-inhibitor","kind":"idea","name":"Adding a checkpoint inhibitor to PSMA radioligand therapy","route":"/ideas/idea-rlt-plus-checkpoint-inhibitor/"}],"trial":[{"id":"prince-trial","kind":"trial","name":"PRINCE","route":"/trials/prince-trial/"}]}}