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Clinical data | |
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Trade names | Cytalux |
Other names | OTL38, OTL-0038 |
License data | |
Pregnancy category |
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Routes of administration | Intravenous |
ATC code | |
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Legal status | |
Identifiers | |
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CAS Number | |
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ChemSpider | |
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ChEMBL | |
Chemical and physical data | |
Formula | C61H67N9O17S4 |
Molar mass | 1326.49 g·mol−1 |
3D model ( JSmol) | |
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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]
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]
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]
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]
![]() | |
Clinical data | |
---|---|
Trade names | Cytalux |
Other names | OTL38, OTL-0038 |
License data | |
Pregnancy category |
|
Routes of administration | Intravenous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
| |
CAS Number | |
PubChem CID | |
DrugBank | |
ChemSpider | |
UNII | |
KEGG | |
ChEMBL | |
Chemical and physical data | |
Formula | C61H67N9O17S4 |
Molar mass | 1326.49 g·mol−1 |
3D model ( JSmol) | |
| |
|
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]
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]
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]
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]