NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Nov 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALAVEN (eribulin mesylate) is a small-molecule tubulin-targeting antimitotic agent approved for multiple solid tumors including breast cancer, soft tissue sarcoma, and ovarian cancer. It works by disrupting mitotic spindles and causing G2/M cell-cycle arrest, leading to apoptotic cell death. The drug also modulates tumor microenvironment vascular perfusion to reduce hypoxia.
$0.618MPart D
LOE ApproachingDeclining
1.2 years to LOEWith only 1.2 years until loss of exclusivity and minimal Part D claims (90 in 2023), the HALAVEN brand team faces significant contraction requiring portfolio transition and cost-optimization focus.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients
Started Jun 2018
6 enrolled
Metastatic Urothelial Cell Cancer
Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)
Started Apr 2018
23 enrolled
Relapsed/Refractory RhabdomyosarcomaNon-rhabdomyosarcoma Soft Tissue SarcomaEwing Sarcoma
A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
Started Mar 2018
200 enrolled
Breast Neoplasms
A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab
Started Aug 2017
446 enrolled
Breast Cancer
A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
Started Mar 2017
90 enrolled
Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.