Pafolacianine

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Pafolacianine
Pafolacianine skeletal.svg
Names
Trade namesCytalux
Other namesPafolacianine sodium, OTL38, OTL-0038
  • 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
Clinical data
Main usesDetecting ovarian cancer during surgery[1]
Side effectsNausea, vomiting, abdominal pain, flushing, chest discomfort, itching, allergic reactions[1]
Pregnancy
category
  • Not recommended[1]
Routes of
use
Intravenous
External links
US NLMPafolacianine
Legal
License data
Legal status
Chemical and physical data
FormulaC61H67N9O17S4
Molar mass1326.49 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 imaging agent used in fluorescence-guided surgery.[1] Specifically it is used to find areas of ovarian cancer.[1] It is given by injection into a vein.[1]

Common side effects include nausea, vomiting, abdominal pain, flushing, chest discomfort, itching, and allergic reactions.[1] Use during pregnancy may harm the baby.[1] It is a fluorescent medication that binds to the folate receptor, which often occurs in high amounts in ovarian cancer.[1]

Pafolacianine was approved for medical use in the United States in 2021.[1] Other similar used agents include methylene blue, fluorescein sodium, and 5-ALA.[3]

Medical uses

Pafolacianine is indicated as an adjunct for intraoperative identification of malignant lesions in people with ovarian cancer.[1][2]

Intraoperative imaging of a squamous cell carcinoma of the lung with pafolacianine.[4]

Dosage

It is generally given as 0.025 mg/kg one to nine hours before surgery.[1]

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.[2][5] 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][5]

The U.S. Food and Drug Administration (FDA) granted the application for pafolacianine orphan drug, priority review, and fast track designations.[2][5][6] The FDA granted the approval of Cytalux to On Target Laboratories, LLC.[2]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 "Cytalux- pafolacianine injection injection". DailyMed. Archived from the original on 19 December 2021. Retrieved 18 December 2021.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 "FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions". U.S. Food and Drug Administration (FDA) (Press release). 29 November 2021. Archived from the original on 30 November 2021. Retrieved 30 November 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  3. Lauwerends, LJ; Abbasi, H; Bakker Schut, TC; Van Driel, PBAA; Hardillo, JAU; Santos, IP; Barroso, EM; Koljenović, S; Vahrmeijer, AL; Baatenburg de Jong, RJ; Puppels, GJ; Keereweer, S (June 2022). "The complementary value of intraoperative fluorescence imaging and Raman spectroscopy for cancer surgery: combining the incompatibles". European journal of nuclear medicine and molecular imaging. 49 (7): 2364–2376. doi:10.1007/s00259-022-05705-z. PMID 35102436.
  4. Predina JD, Newton AD, Xia L, Corbett C, Connolly C, Shin M, et al. (March 2018). "An open label trial of folate receptor-targeted intraoperative molecular imaging to localize pulmonary squamous cell carcinomas". Oncotarget. 9 (17): 13517–13529. doi:10.18632/oncotarget.24399. PMC 5862595. PMID 29568374.
  5. 5.0 5.1 5.2 "FDA approves pafolacianine for identifying malignant ovarian cancer lesions". U.S. Food and Drug Administration (FDA). 1 December 2021. Archived from the original on 2 December 2021. Retrieved 2 December 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  6. "Pafolacianine Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 23 December 2014. Archived from the original on 1 December 2021. Retrieved 30 November 2021.

External links

Identifiers:
  • "Pafolacianine". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-12-01. Retrieved 2022-10-20.