Pafolacianine
Fluorescent drug
From Wikipedia, the free encyclopedia
Pafolacianine, sold under the brand name Cytalux, is an optical imaging agent used in fluorescence-guided surgery.[1][2][3][4][5][6] Pafolacianine is a fluorescent medication that binds to folate receptor (FR)-expressing cells.[1]
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| Trade names | Cytalux |
| Other names | OTL38, OTL-0038 |
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| Routes of administration | Intravenous |
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| Formula | C61H67N9O17S4 |
| Molar mass | 1326.49 g·mol−1 |
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The most common side effects of pafolacianine include infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.[2][4]
It was approved for medical use in the United States in November 2021.[2][7][6] The U.S. Food and Drug Administration considers it to be a first-in-class medication.[8]
Medical uses
Pafolacianine is indicated as an adjunct for intraoperative identification of malignant lesions in people with ovarian cancer.[1][2] It is also indicated to assist identifying lung cancer lesions in adults with known or suspected lung cancer.[3]
History
Scientists from Purdue University designed and developed OTL38 and licensed it to On Target Laboratories in 2013.[9][10] The safety and effectiveness of pafolacianine was evaluated in a randomized, multi-center, open-label study of women diagnosed with ovarian cancer or with high clinical suspicion of ovarian cancer who were scheduled to undergo surgery.[2][4] Of the 134 women (ages 33 to 81 years) who received a dose of pafolacianine and were evaluated under both normal and fluorescent light during surgery, 26.9% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection.[2][4]
The safety and effectiveness of pafolacianine was evaluated in a randomized, multicenter, open-label study (NCT04241315) of participants with known or suspected lung cancer who were scheduled to undergo surgery.[3] Of the 110 participants who received a dose of pafolacianine and were evaluated under both normal and fluorescent light during surgery, 24% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection.[3]
The U.S. Food and Drug Administration (FDA) granted the application for pafolacianine orphan drug, priority review, and fast track designations.[2][4][11][8] The FDA granted the approval of Cytalux to On Target Laboratories, LLC.[2][3]
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