Pafolacianine
An injected dye that makes ovarian and lung cancer deposits glow during surgery so surgeons can find lesions they would otherwise miss.
Phase 3 in ovarian cancer (2021): additional lesions found in 27-33% of patients; ELUCIDATE in lung (2022): 24% had otherwise-undetected lesions or margins. Approved November 2021 (ovarian) and December 2022 (lung). Requires NIR imaging systems in theatre; folate-containing supplements are held.
- Medicare
- Part B (clinician-administered)
Intraoperative imaging agent given before surgery; bundled into the hospital procedure payment (Part A inpatient or Part B outpatient) rather than paid as a drug. CMS granted temporary pass-through payment in the outpatient setting after approval.
- Commercial insurance
- variable
Bundled into the surgical claim; coverage follows the surgery. Some plans class it as investigational.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Inpatient hospital care (Part A). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: pafolacianine. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Intraoperative imaging of ovarian cancer lesions in adults |
| US | 2022 | Intraoperative identification of lung lesions |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Pafolacianine" OR ABSTRACT:"Pafolacianine" OR TITLE:"Cytalux" OR ABSTRACT:"Cytalux") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pafolacianine, not a curated reading list.
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