NDAINJECTIONINJECTABLEPriority Review
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYCAMTIN (topotecan hydrochloride) is a topoisomerase I inhibitor administered by injection for the treatment of advanced ovarian cancer, small cell lung cancer, and cervical cancer. The drug works by inhibiting topoisomerase I, an enzyme essential for DNA replication, thereby inducing apoptosis in rapidly dividing cancer cells.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30%), brand teams are likely consolidating and transitioning toward lifecycle extension strategies or managed decline.
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 (4)
Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
Started Mar 2015
178 enrolled
Adult LiposarcomaMetastatic LiposarcomaMetastatic Osteosarcoma+4 more
Regulatory Hycamtin(Oral) PMS
Started Oct 2010
92 enrolled
Lung Cancer, Small Cell
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
Started Dec 2006
472 enrolled
Lung Cancer, Non-Small Cell
First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin
Started Jun 2005
33 enrolled
Lung Cancer, Small Cell
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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.