NDAINJECTIONINJECTABLEPriority Review
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
HYCAMTIN (topotecan hydrochloride) by Novartis is single-strand breaks. First approved in 1996.
Drug data last refreshed 20h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYCAMTIN (topotecan hydrochloride) is a small-molecule topoisomerase I inhibitor approved in 1996 for treatment of multiple solid tumors and hematologic malignancies including ovarian, cervical, and lung cancers, as well as neuroblastoma and myelodysplastic syndromes. It works by binding to topoisomerase I-DNA complexes and preventing re-ligation of single-strand breaks, leading to double-strand DNA damage during replication that mammalian cells cannot efficiently repair. The drug is administered via injection and represents a legacy chemotherapy option in an increasingly competitive oncology landscape.
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team is likely consolidating and focusing on retention rather than growth initiatives.
Mechanism of Action
single-strand breaks. Topotecan binds to the topoisomerase I‑DNA complex and prevents re-ligation of these single-strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex…
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.