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Cytalux FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 30, 2021.

FDA Approved: Yes (First approved November 29, 2021)
Brand name: Cytalux
Generic name: pafolacianine
Dosage form: Injection
Company: On Target Laboratories, Inc.
Treatment for: Diagnosis and Investigation

Cytalux (pafolacianine) is a fluorescent imaging agent indicated as an adjunct for the intraoperative identification of malignant lesions in patients with ovarian cancer.

  • Cytalux is a fluorescent drug that targets the folate receptor (FR), which may be overexpressed in patients with ovarian cancer. 
  • Cytalux works by binding to FR-expressing cancer cells to illuminate the ovarian cancer. This enables the location of additional malignant tissue that is normally difficult to detect during surgery.
  • Cytalux is administered intravenously over 60 minutes, 1 hour to 9 hours prior to surgery. Folic acid may reduce the detection of cancerous tissue so patients receiving Cytalux are advised to avoid folate, folic acid, or folate-containing supplements within 48 hours before administration.
  • Cytalux may cause serious adverse reactions including infusion-related reactions. Common adverse reactions include nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, pruritus and hypersensitivity.

Development timeline for Cytalux

Nov 29, 2021Approval FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery
Mar  3, 2021On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Pafolacianine Sodium Injection for Identification of Ovarian Cancer During Surgery

Further information

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