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NCE-1 Intelligence & Market Opportunity

Cytalux

Pafolacianine
Diagnostic agent
Intravenous Solution

Surgeons removing ovarian cancer rely on sight and touch to find every deposit, and microscopic residual disease drives recurrence. Cytalux (pafolacianine) made some of that tissue visible.

Injected before surgery, it binds folate receptor alpha, overexpressed on many ovarian tumors, and fluoresces under near-infrared light so surgeons can detect lesions that inspection alone would miss. It is approved as an adjunct for intraoperative identification of malignant lesions in adults with ovarian cancer.

Cytalux later added a lung cancer indication, extending it beyond gynecologic surgery. Its adoption depends on surgeons having compatible near-infrared imaging systems, making the installed base of that equipment, rather than the drug itself, the main constraint on uptake.

Approval Date
29-Nov-21
NCE-1 Date
29-Nov-25
NCE Date
29-Nov-26
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
NA
2027
NA
2028
NA
2029
NA
2030
NA
2031
NA
2032
NA
Molecule profile

Details & specifications

Molecule
Pafolacianine
Innovator
ON TARGET LABORATORIES, INC.
Dosage Form
Intravenous Solution
Strength
EQ 3.2 mg base/1.6 mL (EQ 2 mg base/mL)
Therapeutic Category
Diagnostic agent
Usage
To help identify ovarian cancer lesions
Good to know

Frequently asked questions

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