{"entity":{"id":"amrubicin","kind":"drug","name":"Amrubicin","aka":["Calsed","SM-5887"],"tldr":"Amrubicin is a Japanese anthracycline approved there in 2002 for small cell and non-small cell lung cancer, a standard second-line option for small cell lung cancer in Japan that failed to beat topotecan in a Western phase 3 trial and now serves as the comparator in global trials.","summary":"Sumitomo Dainippon's amrubicin was approved in Japan in 2002 for small cell and non-small cell lung cancer. Japanese trials established it as second-line treatment for relapsed small cell lung cancer, where response rates exceeded topotecan's, but the international ACT-1 phase 3 trial showed no overall survival advantage over topotecan and it was never approved in the United States or Europe. It remains in Japanese guidelines, and current phase 3 trials of new agents such as tarlatamab and ifinatamab deruxtecan use it as one of the standard comparator arms.","status":"established","asOf":"2026-09-16","wikipedia":"https://en.wikipedia.org/wiki/Amrubicin","links":[{"label":"ClinicalTrials.gov: trials of Amrubicin","url":"https://clinicaltrials.gov/search?intr=Amrubicin"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["top2a"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct07365241","nct05740566","nct06203210"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"modality":"Synthetic anthracycline (topoisomerase II inhibitor), intravenous","mechanism":"A fully synthetic anthracycline whose active metabolite amrubicinol poisons topoisomerase II; it causes less cardiotoxicity than doxorubicin in preclinical models.","approvals":[{"region":"JP","year":2002,"indication":"Small cell lung cancer and non-small cell lung cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/amrubicin/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"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/"}],"target":[{"id":"top2a","kind":"target","name":"Topoisomerase II alpha (TOP2A)","route":"/targets/top2a/"}],"trial":[{"id":"nct06203210","kind":"trial","name":"A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer","route":"/trials/nct06203210/"},{"id":"nct07365241","kind":"trial","name":"A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer","route":"/trials/nct07365241/"},{"id":"nct05740566","kind":"trial","name":"Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer","route":"/trials/nct05740566/"},{"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/"}]}}