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Ovarian cancer
Pafolacianine
Другие языки:

Pafolacianine

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Pafolacianine
Pafolacianine skeletal.svg
Clinical data
Trade names Cytalux
Other names OTL38, OTL-0038
License data
Pregnancy
category
  • Not recommended
Routes of
administration		 Intravenous
ATC code
Legal status
Legal status
Identifiers
  • 2-{(E)-2-[(3E)-2-(4-{2-[(4-{[(2-Amino-4-oxo-3,4-dihydro-6-pteridinyl)methyl]aminobenzoyl)amino]-2-carboxyethyl}}phenoxy)-3-{(2E)-2-[3,3-dimethyl-5-sulfo-1-(4-sulfobutyl)-1,3-dihydro-2H-indol-2-ylidene]ethylidene}-1-cyclohexen-1-yl]vinyl}-3,3-dimethyl-1-(4-sulfobutyl)-3H-indolium-5-sulfonate
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)
  • CC1(C2=C(C=CC(=C2)S(=O)(=O)[O-])[N+](=C1C=CC3=C(C(=CC=C4C(C5=C(N4CCCCS(=O)(=O)O)C=CC(=C5)S(=O)(=O)O)(C)C)CCC3)OC6=CC=C(C=C6)CC(C(=O)O)NC(=O)C7=CC=C(C=C7)NCC8=CN=C9C(=N8)C(=O)NC(=N9)N)CCCCS(=O)(=O)O)C
  • InChI=1S/C61H67N9O17S4/c1-60(2)46-33-44(90(81,82)83)22-24-49(46)69(28-5-7-30-88(75,76)77)51(60)26-16-38-10-9-11-39(17-27-52-61(3,4)47-34-45(91(84,85)86)23-25-50(47)70(52)29-6-8-31-89(78,79)80)54(38)87-43-20-12-37(13-21-43)32-48(58(73)74)66-56(71)40-14-18-41(19-15-40)63-35-42-36-64-55-53(65-42)57(72)68-59(62)67-55/h12-27,33-34,36,48H,5-11,28-32,35H2,1-4H3,(H9-,62,63,64,66,67,68,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86)/t48-/m0/s1
  • Key:PDXNSXLPXJFETD-DYVQZXGMSA-N

Pafolacianine, sold under the brand name Cytalux, is an optical imaging agent used in fluorescence-guided surgery. Pafolacianine is a fluorescent 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 considers it to be a first-in-class medication.

Medical uses

Pafolacianine is indicated as an adjunct for intraoperative identification of malignant lesions in people with ovarian cancer. It is also indicated to assist identifying lung cancer lesions in adults with known or suspected lung cancer.

History

Scientists from Purdue University 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 (FDA) granted the application for pafolacianine orphan drug, priority review, and fast track designations. The FDA granted the approval of Cytalux to On Target Laboratories, LLC.

Figures

Intraoperative imaging of a squamous cell carcinoma of the lung with OTL38, subsequently renamed pafolacianine. From Predina et al., 2018.

External links

  • "Pafolacianine". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03180307 for "OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer" at ClinicalTrials.gov
  • Clinical trial number NCT04241315 for "ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting (Elucidate)" at ClinicalTrials.gov



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