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Pafolacianine, sold under the brand name Cytalux, is an
optical imaging Medical optical imaging is the use of light as an investigational imaging technique for medical applications, pioneered by American Physical Chemist Britton Chance. Examples include optical microscopy, spectroscopy, endoscopy, scanning laser o ...
agent used in fluorescence-guided surgery. Pafolacianine is a fluorescent
Fluorescence is one of two kinds of photoluminescence, the emission of light by a substance that has absorbed light or other electromagnetic radiation. When exposed to ultraviolet radiation, many substances will glow (fluoresce) with color ...
medication that binds to folate receptor (FR)-expressing cells.
The most common side effects of pafolacianine include infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.
It was approved for medical use in the United States in November 2021. The U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
considers it to be a first-in-class medication
A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...
.
Medical uses
Pafolacianine isindicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
as an adjunct for intraoperative identification of malignant lesions in people with ovarian cancer
Ovarian cancer is a cancerous tumor of an ovary. It may originate from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. The ovary is made up of three different ...
. It is also indicated to assist identifying lung cancer lesions in adults with known or suspected lung cancer.
History
Scientists fromPurdue University
Purdue University is a Public university#United States, public Land-grant university, land-grant research university in West Lafayette, Indiana, United States, and the flagship campus of the Purdue University system. The university was founded ...
designed and developed OTL38 and licensed it to On Target Laboratories in 2013. 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. 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.
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. 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.
The U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) granted the application for pafolacianine orphan drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...
, priority review
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...
, and fast track designations. The FDA granted the approval of Cytalux to On Target Laboratories, LLC.
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References
External links
* * * {{Portal bar , Medicine Optical imaging Orphan drugs Ovarian cancer Carboxylic acids Sulfonic acids Sulfonates Pteridines