NDAINJECTIONINJECTABLEPriority Review
Approved
Jun 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAMPTOSAR (irinotecan hydrochloride) is a small-molecule topoisomerase I inhibitor used in chemotherapy regimens for colorectal cancer and other solid tumors. It works by inhibiting topoisomerase I, an enzyme essential for DNA replication, leading to DNA damage and cancer cell death. The drug is administered intravenously and is often combined with fluorouracil and leucovorin (5-FU/LV).
LOE Approaching
As a near-LOE product with moderate competitive pressure (30%), brand teams face resource constraints and focus shifts toward managed care negotiations and market defense rather than expansion.
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 (12)
Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma
Started Jun 2024
20 enrolled
Biliary Tract Carcinoma
Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
Started Apr 2024
3,000 enrolled
Pancreatic Cancer
Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer
Started Sep 2020
66 enrolled
Small Cell Lung Cancer
Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors
Started Feb 2019
38 enrolled
Advanced Solid Tumor
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
Started Mar 2018
40 enrolled
Refractory or Recurrent Solid TumorsRhabdomyosarcomaNon-Rhabdomyosarcoma Soft Tissue Sarcoma+1 more
Worked on CAMPTOSAR at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.