EPIRUBICIN HYDROCHLORIDE
Epirubicin helps patients with breast cancer that has spread to the axillary lymph nodes. It is used as a component of additional therapy following the surgical removal of the primary tumor. This medication is prescribed to target remaining cancer cells and support the overall recovery process after surgery.
How EPIRUBICIN HYDROCHLORIDE Works
This drug works by binding directly to DNA, inserting itself between base pairs to block the production of essential proteins and nucleic acids. It also interferes with enzymes like topoisomerase II and DNA helicase, which leads to DNA damage and prevents cancer cells from replicating. Additionally, the medication creates harmful free radicals that contribute to the destruction of tumor cells.
Details
- Status
- Prescription
- First Approved
- 2006-09-15
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
Companies
EPIRUBICIN HYDROCHLORIDE Approval History
What EPIRUBICIN HYDROCHLORIDE Treats
1 indicationsEPIRUBICIN HYDROCHLORIDE is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast cancer with axillary lymph node involvement (post-surgery)
EPIRUBICIN HYDROCHLORIDE Boxed 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 ventricu...
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.
EPIRUBICIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EPIRUBICIN HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EPIRUBICIN HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06797635 | 1022-010 MK-1022-010, 2024-514376-40-00 | Ph 2 | recruiting | 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) |
| NCT06829199 | 5890-003 MK-5890-003, 2024-517505-87-00 | Ph 2 | withdrawn | A Clinical Study of Boserolimab (MK-5890) With Pembrolizumab and Chemotherapy in People With Early Triple-Negative Breast Cancer (MK-5890-003) |
| NCT04418154 NeoTENNIS | SCHBCC-N027 | Ph 2 | active not recruiting | Neoadjuvant Dose-dense EC Followed by ABX With PD-1 for Triple Negative Breast Cancer Patients |
| NCT02315196 results posted | 041401 NCI-2014-02029, Pro20140000477041401 | Ph 2 | active not recruiting | Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer |
| NCT02050919 results posted | IRB00009464 NCI-2013-02414, IRB00009464 | Ph 2 | completed | Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma |
| NCT00820547 Beverly1 | PACS09 UC-0140/0802 UNICANCER-PACS-09-0802, 2008-001807-53 | Ph 2 | completed | Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients |
| NCT00601705 results posted | CASE2Y07 P30CA043703, CASE2Y07 | Ph 2 | completed | Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach |
| NCT00822848 | IRB00004653 P30CA069533, OHSU-4653 | Ph 1 | completed | Sorafenib, Epirubicin, Ifosfamide, and Radiation Therapy Followed By Surgery in Treating Patients With High-Risk Stage II or Stage III Soft Tissue Sarcoma |
| NCT01624441 | NCI-2012-00950 NCI-2012-00950, 2012-0229 | Ph 1 | completed | Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer |
| NCT00878904 | CDR0000639080 UCSF-09991, NOVARTIS-CLBH589C | Ph 1 | completed | Panobinostat and Epirubicin in Treating Patients With Metastatic Malignant Solid Tumors |
| NCT01123473 | EORTC-40071 EU-21036, 2009-011580-36 | Ph 2 | terminated | Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer |
| NCT00963729 | ICCRU-NEOcent-C-21-07 CDR0000641383, ICCRU-NEOcent-C-21-07 | Ph 3 | completed | Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EPIRUBICIN HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)EPIRUBICIN HYDROCHLORIDE is indicated for the treatment of Breast cancer with axillary lymph node involvement (post-surgery).
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 incide...
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ELLENCE
Full clinical data, patents, trials, and competitive landscape for epirubicin hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.