CYTALUX
Peakpafolacianine injection
NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
CYTALUX (pafolacianine injection) is 12. Approved for ovarian cancer. First approved in 2021.
Drug data last refreshed 13h ago · AI intelligence enriched 3mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYTALUX (pafolacianine injection) is a near-infrared fluorescent imaging agent that binds to folate receptors on cancer cells, enabling real-time surgical visualization of ovarian cancer lesions. It works by targeting alpha and beta folate receptors expressed at high levels on tumor cells, accumulating intracellularly and emitting fluorescence in the 790–815 nm range under near-infrared light. This intravenous diagnostic agent enhances tumor-to-background contrast during surgical procedures.
Peak9.1 years to LOE
CYTALUX is in peak lifecycle stage with stable patent protection through 2035; brand teams may focus on market penetration and physician adoption in surgical oncology centers.
Mechanism of Action
12.1 Mechanism of Action Pafolacianine binds to alpha and beta folate receptors (FR) on cells, is internalized via receptor-mediated endocytosis, and accumulates intracellularly. Pafolacianine enhances lesion visualization through the differential level of expression and accessibility of folate…
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.