NDAORALCAPSULEPriority Review
Approved
Oct 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
HYCAMTIN (topotecan) by Novartis is single-strand breaks. First approved in 2007.
Drug data last refreshed 21h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYCAMTIN (topotecan) is an oral small-molecule topoisomerase I inhibitor approved for small cell lung cancer, ovarian cancer, and platinum-resistant ovarian cancers. It works by binding to the topoisomerase I-DNA complex and preventing re-ligation of single-strand breaks, leading to double-strand DNA damage during replication that mammalian cells cannot repair. The drug is indicated across multiple gynecologic and pulmonary malignancies.
LOE Approaching
Product approaching loss of exclusivity with 30% competitive pressure intensity; expect defensive positioning and consolidation of brand and supporting teams.
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 (20)
Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
Started Aug 2025
600 enrolled
SCLC
Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer
Started Aug 2025
128 enrolled
Extensive-stage Small Cell Lung Cancer (ES-SCLC)Extensive-stage Small Cell Lung Cancer (SCLC)Small Cell Lung Cancer ( SCLC )
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Started Sep 2024
180 enrolled
Relapsed Small Cell Lung Cancer
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)
Started Aug 2024
722 enrolled
Small Cell Lung Cancer
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Started Oct 2023
302 enrolled
Extensive-stage Small-cell Lung 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.