# Daunorubicin

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

## TL;DR

Daunorubicin is the anthracycline most often combined with cytarabine to bring acute myeloid leukaemia into remission; it is also part of induction for acute lymphoblastic leukaemia.

## Summary

Daunorubicin, isolated from Streptomyces in the 1960s, was approved in 1979 for remission induction in acute non-lymphocytic leukaemia in adults and in acute lymphocytic leukaemia in adults and children, in combination with other agents. With cytarabine it forms the 7+3 regimen that has anchored AML induction for fifty years; the label reports complete remission rates of 53 to 65% for the combination. A liposomal fixed-ratio co-formulation with cytarabine (CPX-351, Vyxeos, 2017) improved survival in secondary AML and has its own record. Cumulative dose-dependent cardiomyopathy limits lifetime exposure, and extravasation causes severe tissue necrosis.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: Daunomycin; Rubidomycin
- Tags: nci-list; generic
- Brand: Cerubidine (historic)
- Modality: Anthracycline (topoisomerase II inhibitor)
- Mechanism: Intercalates DNA and stabilises the topoisomerase II cleavage complex, causing double-strand breaks; generates free radicals responsible for cardiotoxicity.
- Approvals: US 1979: Remission induction in acute non-lymphocytic leukaemia (adults) and acute lymphocytic leukaemia (adults and children), in combination

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Daunorubicin
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=daunorubicin
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/daunorubicinhydrochloride

## Connected records

- drugs: [CPX-351 (liposomal daunorubicin-cytarabine)](https://onco.cc/drugs/cpx-351/), [Cytarabine + anthracycline ('7+3')](https://onco.cc/drugs/cytarabine-7-3/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Idarubicin](https://onco.cc/drugs/idarubicin/)
- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Acute myeloid leukaemia in children](https://onco.cc/cancers/aml-paediatric/), [High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)](https://onco.cc/cancers/all-paediatric-high-risk/), [Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year)](https://onco.cc/cancers/all-infant/), [Myeloid leukaemia of Down syndrome](https://onco.cc/cancers/myeloid-leukaemia-of-down-syndrome/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- trials: [A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML](https://onco.cc/trials/nct03591510/), [A Safety and Efficacy Study of Eltrombopag in Subjects With AML](https://onco.cc/trials/nct01890746/), [A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia](https://onco.cc/trials/nct07255872/), [A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations](https://onco.cc/trials/nct04293562/), [Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia](https://onco.cc/trials/nct00703820/), [Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations](https://onco.cc/trials/nct02883049/), [Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia](https://onco.cc/trials/nct00003436/), [Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia](https://onco.cc/trials/nct00557193/), [Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia](https://onco.cc/trials/nct00002658/), [Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia](https://onco.cc/trials/nct03150693/), [International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia](https://onco.cc/trials/nct01117441/), [Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome](https://onco.cc/trials/nct02521493/), [Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia](https://onco.cc/trials/nct02072811/), [Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML](https://onco.cc/trials/nct07007312/), [Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated](https://onco.cc/trials/nct04778397/), [Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia](https://onco.cc/trials/nct00136084/)
- key papers: [CPX-351 versus 7+3 chemotherapy in older adults with newly diagnosed secondary acute myeloid leukaemia](https://onco.cc/key-papers/paper-cpx-351-study-301-lancet-je-jco-2018/)

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