{"entity":{"id":"lurbinectedin","kind":"drug","name":"Lurbinectedin","aka":[],"tldr":"A marine-derived chemotherapy that jams cancer's gene-reading machinery, approved for relapsed small-cell lung cancer and, since 2025, as first-line maintenance with atezolizumab.","summary":"Accelerated approval June 2020 for metastatic SCLC after platinum (ORR 35%, DOR 5.3 months, basket phase 2). ATLANTIS (with doxorubicin) missed OS; IMforte (with atezolizumab as first-line maintenance) improved OS and PFS, leading to full approval on 2 October 2025. Also studied in the LAGOON second-line trial. Jazz Pharmaceuticals (US) and PharmaMar.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Lurbinectedin","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lurbinectedin"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc","lung-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["jazz","pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":["imforte","atlantis","nct07625644","nct06801834","nct06496048","nct05652686","nct05734066","nct07155174","nct07459634","nct06088290","lurbinectedin-basket-sclc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Lurbinectedin has no United Kingdom marketing authorisation and no NICE appraisal, so it is not available on the NHS in England, although it holds FDA approval (accelerated, 15 June 2020, converted on the IMforte maintenance data) and an EU authorisation for maintenance with atezolizumab."],"brand":"Zepzelca","code":"PM01183","modality":"Cytotoxic (transcription inhibitor)","mechanism":"Binds the DNA minor groove at CG-rich promoters, stalls RNA polymerase II and triggers its degradation; also depletes tumour-associated macrophages.","approvals":[{"region":"US","year":2020,"indication":"Metastatic SCLC after platinum chemotherapy (accelerated)"},{"region":"US","year":2025,"indication":"First-line maintenance with atezolizumab in ES-SCLC (full approval)"},{"region":"EU","year":2026,"indication":"Maintenance with atezolizumab in ES-SCLC after first-line induction; 29 May 2026"}],"mechanismSteps":["Binds guanine in the DNA minor groove at active promoters","Elongating RNA polymerase II stalls and is degraded","Transcription-dependent double-strand breaks accumulate","Cells with high transcriptional addiction (SCLC, TP53-mutant) die; macrophage depletion reduces immunosuppression"],"dosing":{"route":"Intravenous","schedule":"3.2 mg/m² over 60 minutes every 21 days (monotherapy); with atezolizumab 1200 mg in maintenance","modifications":"Delay and reduce for grade 3-4 neutropenia or hepatotoxicity","monitoring":"Blood counts and liver enzymes before each cycle","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213702s004lbl.pdf"},"toxicity":[{"event":"Neutropenia","anyGradePct":71,"grade3PlusPct":46},{"event":"Fatigue","anyGradePct":77},{"event":"Nausea","anyGradePct":37},{"event":"Transaminase increase","anyGradePct":66}],"access":[],"regulatoryEvents":[{"date":"2020-06-15","type":"accelerated-approval","region":"US","note":"Accelerated approval, second-line SCLC The confirmatory requirement was still open 6.3 years later, when the FDA's table was read.","indication":"Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after prior platinum-based chemotherapy ."},{"date":"2025-10-02","type":"approval","region":"US","note":"Full approval with atezolizumab as first-line maintenance (IMforte)","source":"https://www.roche.com/media/releases/med-cor-2025-10-03b"}]},"route":"/drugs/lurbinectedin/","neighbours":{"cancer":[{"id":"ewing-sarcoma","kind":"cancer","name":"Ewing sarcoma","route":"/cancers/ewing-sarcoma/"},{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"id":"limited-stage-sclc","kind":"cancer","name":"Limited-stage small-cell lung cancer","route":"/cancers/limited-stage-sclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"prostate-nepc","kind":"cancer","name":"Neuroendocrine and small-cell prostate cancer","route":"/cancers/prostate-nepc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"company":[{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"},{"id":"pharmamar","kind":"company","name":"PharmaMar","route":"/companies/pharmamar/"}],"trial":[{"id":"nct07459634","kind":"trial","name":"A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC","route":"/trials/nct07459634/"},{"id":"nct05652686","kind":"trial","name":"A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)","route":"/trials/nct05652686/"},{"id":"nct07796100","kind":"trial","name":"A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Ther","route":"/trials/nct07796100/"},{"id":"nct07155174","kind":"trial","name":"A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus St","route":"/trials/nct07155174/"},{"id":"atlantis","kind":"trial","name":"ATLANTIS","route":"/trials/atlantis/"},{"id":"nct07625644","kind":"trial","name":"BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)","route":"/trials/nct07625644/"},{"id":"ideate-lung02","kind":"trial","name":"IDeate-Lung02","route":"/trials/ideate-lung02/"},{"id":"imforte","kind":"trial","name":"IMforte","route":"/trials/imforte/"},{"id":"lurbinectedin-basket-sclc","kind":"trial","name":"Lurbinectedin basket trial, small-cell lung cancer cohort","route":"/trials/lurbinectedin-basket-sclc/"},{"id":"nct06496048","kind":"trial","name":"Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC","route":"/trials/nct06496048/"},{"id":"nct07153055","kind":"trial","name":"Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","route":"/trials/nct07153055/"},{"id":"nct06088290","kind":"trial","name":"Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)","route":"/trials/nct06088290/"},{"id":"nct05734066","kind":"trial","name":"Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma","route":"/trials/nct05734066/"},{"id":"nct06801834","kind":"trial","name":"Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer","route":"/trials/nct06801834/"},{"id":"nct05578326","kind":"trial","name":"Study of Trilaciclib and Lurbinectidin","route":"/trials/nct05578326/"}],"pairing":[{"id":"chemo-io-then-maintenance-sclc","kind":"pairing","name":"Chemo-immunotherapy induction → maintenance intensification (SCLC)","route":"/pairings/chemo-io-then-maintenance-sclc/"}],"term":[{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"},{"id":"sclc-molecular-subtypes","kind":"term","name":"Small-cell lung cancer transcription-factor subtypes (SCLC-A, SCLC-N, SCLC-P, SCLC-I) and SLFN11","route":"/terms/sclc-molecular-subtypes/"}],"target":[{"id":"ewsr1-fli1","kind":"target","name":"EWSR1-FLI1 fusion","route":"/targets/ewsr1-fli1/"}],"pathway":[{"id":"sclc-signalling","kind":"pathway","name":"Small cell lung cancer (KEGG map)","route":"/pathways/sclc-signalling/"}],"drug":[{"id":"tk216","kind":"drug","name":"TK216","route":"/drugs/tk216/"}]}}