# Pafolacianine

Source: https://onco.cc/drugs/pafolacianine/  
OnCo record `pafolacianine` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An injected dye that makes ovarian and lung cancer deposits glow during surgery so surgeons can find lesions they would otherwise miss.

## Summary

Pafolacianine is a folate analogue conjugated to an indocyanine near-infrared dye. Injected before surgery, it binds folate receptor alpha, which is overexpressed on ovarian and lung adenocarcinoma cells, and fluoresces under NIR light so surgeons can see tumour deposits they would otherwise miss. In the phase 3 ovarian trial (2021) additional lesions were found in 27 to 33% of patients, and in ELUCIDATE in lung cancer (2022) 24% of patients had otherwise-undetected lesions or positive margins revealed. The FDA approved it in November 2021 for intraoperative imaging of ovarian cancer and in December 2022 for lung lesions; it requires NIR imaging systems in theatre, and folate-containing supplements are withheld beforehand. Whether finding more lesions improves survival is unproven. In short, pafolacianine makes cancer glow so the surgeon can find it.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill; diagnostic
- Brand: Cytalux
- Modality: Folate receptor-targeted near-infrared fluorescent imaging agent
- Mechanism: Folate analogue conjugated to an indocyanine dye; binds folate receptor alpha on ovarian and lung adenocarcinoma cells and fluoresces under NIR light during surgery.
- Approvals: US 2021: Intraoperative imaging of ovarian cancer lesions in adults; US 2022: Intraoperative identification of lung lesions

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Pafolacianine
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=pafolacianine

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/)
- technologies: [Fluorescence-guided surgery](https://onco.cc/technologies/fluorescence-guided-surgery/), [Intraoperative fluorescence and Cerenkov imaging systems (SPY, Firefly, LumiSystem, LightPath)](https://onco.cc/technologies/intraoperative-fluorescence-imaging-systems/), [Optical & fluorescence imaging](https://onco.cc/technologies/optical-imaging/)
- targets: [Folate receptor alpha](https://onco.cc/targets/folr1/)
- companies: [On Target Laboratories](https://onco.cc/companies/on-target-laboratories/)
- trials: [CYTALUX™for the Intraoperative Imaging of Prostate Cancer](https://onco.cc/trials/nct06434909/), [ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting](https://onco.cc/trials/nct04241315/), [Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer](https://onco.cc/trials/nct07039526/)

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