# Amrubicin

Source: https://onco.cc/drugs/amrubicin/  
OnCo record `amrubicin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: established
- Last checked: 2026-09-16
- Also known as: Calsed; SM-5887
- Tags: pipeline; ctgov-ingest
- 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: JP 2002: Small cell lung cancer and non-small cell lung cancer

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Amrubicin
- ClinicalTrials.gov: trials of Amrubicin: https://clinicaltrials.gov/search?intr=Amrubicin

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- targets: [Topoisomerase II alpha (TOP2A)](https://onco.cc/targets/top2a/)
- trials: [A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer](https://onco.cc/trials/nct06203210/), [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](https://onco.cc/trials/nct07365241/), [Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer](https://onco.cc/trials/nct05740566/), [Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer](https://onco.cc/trials/nct06801834/)

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JSON: https://onco.cc/api/v1/entities/amrubicin.json