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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. Examples include optical microscopy, spectroscopy, endoscopy, scanning laser ophthalmoscopy, laser Doppler imaging, and optical coherence ...
agent used in fluorescence-guided surgery.
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.
Pafolacianine is a fluorescent
Fluorescence is the emission of light by a substance that has absorbed light or other electromagnetic radiation. It is a form of luminescence. In most cases, the emitted light has a longer wavelength, and therefore a lower photon energy, ...
medication that binds to folate receptor
Folate receptors bind folate and reduced folic acid derivatives and mediates delivery of tetrahydrofolate to the interior of cells. It is then converted from monoglutamate to polyglutamate forms - such as 5-methyltetrahydrofolate - as only monog ...
(FR)-expressing cells.
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 c ...
. It is also indicated to assist identifying lung cancer lesions in adults with known or suspected lung cancer.
History
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 respon ...
(FDA) granted the application for pafolacianine orphan drug, 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
The fast track is an informal English term meaning "the quickest and most direct route to achievement of a goal, as in competing for professional advancement". By definition, it implies that a less direct, slower route also exists.
Fast track or F ...
designations. The FDA granted the approval of Cytalux to On Target Laboratories, LLC.
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References
External links
* * * Optical imaging Orphan drugs Ovarian cancer Carboxylic acids Sulfonic acids Sulfonates Pteridines {{Pharma-stub