The U.S. Food and Drug Administration (FDA) has approved paforacyanin (Cytalux) as an injectable contrast agent for adults with lung cancer.
of new approvalGranted following priority review, this contrast agent is the second indication for a contrast agent used to illuminate tumors during surgery.of initial approvaloccurred in November 2021. ovarian cancer.
According to drug maker On Target Laboratories, paforacyanin is “the first and only targeted molecular contrast agent that illuminates lung and ovarian cancer during surgery, allowing more cancer to be detected and removed.” is.
“When administered by standard IV immediately prior to surgery, Cytalux folic acid A receptor that is overexpressed in most epithelial ovarian cancers and most lung adenocarcinomas (the most common type of lung cancer) and glows under near-infrared light during surgery,” the company said. Explanation of press release.
The FDA approved this expanded indication based on findings from an open-label, multicenter, Phase 3 trial. ELUCIDATE exam, We investigated paforacyanin injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.
Of the 110 study participants who received contrast, 24% had at least one cancerous lesion that was not observed by standard visual or tactile examination.
“During the ELUCIDATE trial, Cytalux proved to be a valuable surgical tool with its ability to localize pulmonary lesions that might otherwise have been missed.”, “The standard in thoracic surgery.” It could be a cure,” said Linda Martin, MD, MPH, Chief, Ph.D. in Thoracic Surgery from the University of Virginia School of Medicine, according to a press release.
Infusion-related reactions such as nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching, and hypersensitivity occurred in 1% to 13% of patients enrolled in the study, with nausea and vomiting being the most frequent Did. These reactions may be treated with antihistamines and/or anti-nausea drugs, according to On Target Laboratories.
Cytalux can cause fetal harm when administered to pregnant women, the company stressed, and the use of folic acid folic acidor supplements containing folic acid should be avoided within 48 hours before administering the drug.
“Using Cytalux to detect lung cancer during surgery carries the risk of image interpretation errors such as false negatives and false positives,” said the company’s press release.
Side effects should be reported to On Target Laboratories (1-844-434-9333) or FDA (1-800-FDA-1088) or www.fda.gov/medwatch.
Sharon Worcester (MA) is an award-winning medical journalist based in Birmingham, Alabama who writes for Medscape, MDedge and other affiliate sites. Although she currently deals with oncology, she also writes on various other medical specialties and healthcare topics.she can be reached at [email protected] Or on Twitter: @SW_MedReporter
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