The Food and Drug Administration (FDA) has expanded the approval of Cytalux® (pafolacianine) to include intraoperative identification of malignant and nonmalignant pulmonary lesions in adults with known or suspected lung cancer, in addition to detecting ovarian cancer lesions.

Cytalux is a fluorescent drug that binds to folate receptor (FR)-expressing cancer cells and illuminates intraoperatively under near infrared light. The expanded approval was based on data from the open-label phase 3 ELUCIDATE study (ClinicalTrials.gov Identifier: NCT04241315), which evaluated the efficacy and safety of pafolacianine in 140 adults scheduled to undergo thoracoscopic or open segmental or subsegmental resection for primary lung lesions that were either confirmed or suspected to be cancer.

“During the Elucidate trial, Cytalux proved to be a valuable surgical tool with its ability to localize lung lesions that may have otherwise been missed,” said Dr Linda Martin, Chief of Thoracic Surgery, University of Virginia School of Medicine. “Cytalux has potential to become standard of care in thoracic surgery because of the safety and efficacy demonstrated in the trial. It is an important tool for surgeons to consider for patients.”

The most common adverse reactions reported with pafolacianine were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, blood pressure elevation, and hypersensitivity. Pafolacianine may cause fetal harm; pregnancy testing prior to administration is recommended.

Cytalux is supplied as a single-dose vial containing 3.2mg/1.6mL (2mg/mL) of pafolacianine.

References

  1. On Target Laboratories announces expanded indication of Cytalux® (pafolacianine) injection for detection of lung cancer during surgery. News release. On Target Laboratories, Inc. Accessed December 16, 2022. https://www.multivu.com/players/English/9123551-on-target-laboratories-expanded-indication-cytalux-injection-lung-cancer-detection-during-surgery/.
  2. Cytalux. Package Insert. On Target Laboratories, Inc.; 2021. Accessed December 16, 2021. https://cytalux.com/wp-content/uploads/2022/12/221216_CYTALUX-Prescribing-Information.pdf.