{"entity":{"id":"durvalumab","kind":"drug","name":"Durvalumab","aka":[],"tldr":"A PD-L1 blocker that became standard after chemoradiation for stage III lung cancer, and now in bladder, biliary, and gastric cancers.","summary":"PACIFIC (unresectable stage III NSCLC), ADRIATIC (limited-stage SCLC, 2024), TOPAZ-1 (biliary tract), HIMALAYA (HCC with tremelimumab), NIAGARA (perioperative muscle-invasive bladder cancer, 2025), MATTERHORN (perioperative gastric, 2025), and Q2 2026 high-risk non-muscle-invasive bladder cancer with BCG (POTOMAC). Partner of Dato-DXd in TROPION-Breast05.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Durvalumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Durvalumab"}],"tags":[],"related":[],"indications":["sclc","hcc","hcc-intermediate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05063565","nct06040099"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Imfinzi","modality":"Monoclonal antibody (anti-PD-L1)","mechanism":"Human IgG1 anti-PD-L1 with reduced Fc effector function.","approvals":[{"region":"US","year":2017,"indication":"Locally advanced or metastatic urothelial carcinoma after platinum (accelerated; indication withdrawn 2021)"},{"region":"US","year":2018,"indication":"Unresectable stage III NSCLC after chemoradiation"},{"region":"US","year":2026,"indication":"High-risk NMIBC with BCG"}],"mechanismSteps":["Antibody binds PD-L1","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","schedule":"10 mg/kg every 2 weeks or 1,500 mg every 4 weeks (≥30 kg); up to 12 months after chemoradiation in stage III NSCLC","modifications":"Hold for grade 2 pneumonitis; discontinue for grade 3-4","monitoring":"Respiratory symptoms after chemoradiation, thyroid, LFTs, creatinine","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3"},"toxicity":[{"event":"Pneumonitis (any cause, PACIFIC)","anyGradePct":18.3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"vs 12.8% placebo; 1.1% fatal"},{"event":"Cough","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Fatigue","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Radiation pneumonitis","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Upper respiratory infection","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Dyspnoea","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Rash","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.astrazeneca-us.com/medicines/access-360","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended after chemoradiation in stage III NSCLC (TA798), biliary tract cancer, limited-stage SCLC, perioperative bladder and gastric cancer","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2017-05-01","type":"approval","region":"US","note":"Urothelial carcinoma (accelerated; later withdrawn 2021)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2018-02-16","type":"approval","region":"US","note":"Unresectable stage III NSCLC after chemoradiation (PACIFIC)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-03-27","type":"approval","region":"US","note":"Extensive-stage SCLC with chemotherapy (CASPIAN)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-09-02","type":"approval","region":"US","note":"Biliary tract cancer with chemotherapy (TOPAZ-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-10-21","type":"approval","region":"US","note":"HCC with tremelimumab (HIMALAYA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-12-04","type":"approval","region":"US","note":"Limited-stage SCLC after chemoradiation (ADRIATIC)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-03-28","type":"approval","region":"US","note":"Perioperative muscle-invasive bladder cancer (NIAGARA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-11","type":"approval","region":"US","note":"Perioperative gastric/GEJ cancer with FLOT (MATTERHORN)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-05-28","type":"approval","region":"US","note":"High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder"}]},"route":"/drugs/durvalumab/","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":"sclc","kind":"indication","name":"Small-cell lung cancer","route":"/indications/sclc/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"trial":[{"id":"nct06040099","kind":"trial","name":"A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepat","route":"/trials/nct06040099/"},{"id":"nct05063565","kind":"trial","name":"TheraSphere With Durvalumab and Tremelimumab for HCC","route":"/trials/nct05063565/"}],"pairing":[{"id":"tare-plus-durvalumab-hcc","kind":"pairing","name":"Radioembolisation (TARE) with durvalumab in hepatocellular carcinoma","route":"/pairings/tare-plus-durvalumab-hcc/"}]}}