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
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