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Halaven (ERIBULIN)
Halaven works by binding to tubulin beta, disrupting microtubule dynamics and leading to cell death.
At a glance
| Generic name | ERIBULIN |
|---|---|
| Sponsor | Eisai |
| Drug class | Microtubule Inhibitor |
| Target | Tubulin beta |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2010 |
| Annual revenue | 400 |
Mechanism of action
Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.In addition, eribulin treatment of human breast cancer cells caused changes in morphology and gene expression as well as decreased migration and invasiveness in vitro. In mouse xenograft models of human breast cancer, eribulin treatment was associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with change in phenotype.
Approved indications
- Liposarcoma
- Metastatic Breast Carcinoma
Common side effects
- Neutropenia
- Anemia
- Asthenia/Fatigue
- Peripheral neuropathy
- Nausea
- Constipation
- Pyrexia
- Headache
- Mucosal inflammation
- Vomiting
- Diarrhea
- Arthralgia/Myalgia
Drug interactions
- High Risk QT Prolonging Agents
Key clinical trials
- Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer (PHASE3)
- Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (PHASE1,PHASE2)
- Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer (PHASE1,PHASE2)
- Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer (PHASE2)
- Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer (PHASE3)
- ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (PHASE3)
- Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With ADC
- The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Halaven CI brief — competitive landscape report
- Halaven updates RSS · CI watch RSS
- Eisai portfolio CI