Last reviewed 2026-04-20 · How we verify

Ellence (EPIRUBICIN)

Ellence (generic name: EPIRUBICIN) is a Anthracycline Topoisomerase Inhibitor Small molecule drug developed by Pfizer. It is currently FDA-approved (first approved 1999) for Carcinoma of breast.

Ellence works by intercalating DNA and inhibiting topoisomerase II, disrupting cancer cell growth.

Ellence (Epirubicin) is a small molecule anthracycline topoisomerase inhibitor developed by Pfizer Inc, targeting tyrosine-protein kinase Fyn. It is used to treat breast cancer and was FDA-approved in 1999. Ellence is now off-patent, with multiple generic manufacturers available. Key safety considerations include its potential for cardiotoxicity and myelosuppression. As an anthracycline, it works by intercalating DNA and inhibiting topoisomerase II, disrupting cancer cell growth.

At a glance

Mechanism of action

Epirubicin is an anthracycline cytotoxic agent. Although it is known that anthracyclines can interfere with number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicins cytotoxic and/or antiproliferative properties have not been completely elucidated.Epirubicin forms complex with DNA by intercalation of its planar rings between nucleotide base pairs, with consequent inhibition of nucleic acid (DNA and RNA) and protein synthesis.Such intercalation triggers DNA cleavage by topoisomerase II, resulting in cytocidal activity. Epirubicin also inhibits DNA helicase activity, preventing the enzymatic separation of double-stranded DNA and interfering with replication and transcription. Epirubicin is also involved in oxidation/reduction reactions by generating cytotoxic free radicals. The antiproliferative and cytotoxic activity of epirubicin is thought to result from these or other possible mechanisms.Epirubicin is cytot

Approved indications

• Carcinoma of breast

Boxed warnings

• WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE ( 5.1 ). • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE ( 5.2 ). • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area ( 5.3 ). • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur ( 5.4 ).

Common side effects

• Leukopenia
• Neutropenia
• Anemia
• Thrombocytopenia
• Nausea/vomiting
• Mucositis
• Diarrhea
• Infection
• Conjunctivitis/keratitis
• Alopecia
• Local skin toxicity
• Rash/itch

Key clinical trials

• A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
• Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer (PHASE1,PHASE2)
• A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer (NA)
• LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer (PHASE2)
• Safety and Efficacy of LVD + C-TACE + Tis/Len for Unresectable Right-Liver HCC (NA)
• Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma (PHASE3)
• Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03) (PHASE2)
• Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ellence CI brief — competitive landscape report
• Ellence updates RSS · CI watch RSS
• Pfizer portfolio CI

Frequently asked questions about Ellence

Related

• Drug class: All Anthracycline Topoisomerase Inhibitor drugs
• Target: All drugs targeting Tyrosine-protein kinase Fyn
• Manufacturer: Pfizer — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Carcinoma of breast

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing