TOPOTECAN
LOE ApproachingNDAINTRAVENOUSSOLUTION
Approved
Feb 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
TOPOTECAN by Novartis is single-strand breaks. Approved for after initial, subsequent chemotherapy, recurrent and 1 more indications. First approved in 2011.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Topotecan is a small-molecule topoisomerase I inhibitor approved by the FDA in 2011 as an intravenous solution. It is used to treat certain cancers by inhibiting topoisomerase I, an enzyme critical for DNA replication in rapidly dividing cells. The drug is administered intravenously and represents a targeted approach to cancer therapy.
LOE Approaching
As LOE approaches, the commercial team is likely consolidating resources and transitioning to life-cycle management; expect smaller team sizes and focus on retention of existing market share.
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 (4)
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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.