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 1w ago · AI intelligence enriched 2w 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 and enables enhanced lesion visualization during surgery. It is indicated for ovarian cancer and works by accumulating intracellularly within folate receptor-expressing lesions, allowing surgeons to distinguish cancerous tissue from normal tissue under NIR light (776 nm peak absorption, 796 nm peak emission).
Peak7.4 years to LOE
Product is in peak commercial phase with potential for sustained growth in the ovarian cancer surgical imaging space; brand team likely focused on market expansion and surgical center adoption.
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.