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The FDA has granted fast track designation for abenacianine to help surgeons better visualize lung tumors during minimally invasive surgery.
The Food and Drug Administration (FDA) has granted fast track designations for abenacianine as an adjunct for the intraoperative visualization of primary lung cancer, other pulmonary lesions, cancer containing lymph nodes and positive surgical margins in patients with lung cancer who are undergoing surgery, according to a news release from Vergent Bioscience.
According to the release, abenacianine is an investigational tumor-targeted fluorescent imaging agent that has shown promising results for the safety of the drug and its ability to label human lung tumors during surgery. Specifically, the agent is designed to enable surgeons to see hard-to-find or previously undetected tumors in real-time during surgery to ensure the full removal of all tumor tissue.
“Receiving fast track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” said Dr. John Santini, president and chief executive officer at Vergent Bioscience, in the release. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”
Currently, minimally invasive surgery and robotic-assisted surgery methods are increasingly used in lung cancer resection due to benefits such as shorter hospital stays, smaller incisions, less blood loss and decreased postoperative complications, including chronic pleural pain, according to the release. However, these approaches can limit surgeons' ability to distinguish tumors from normal tissue.
Intraoperative visualization: imaging techniques used during surgery to see inside the body.
Pulmonary lesions: abnormal growths or areas of damage in the lungs.
Positive surgical margins: when a surgeon removes a tumor, they leave a margin of healthy tissue around it. A positive margin means that the edge of the removed tissue contains cancer cells.
Furthermore, clinical studies have shown that abenacianine has the potential to improve the confidence of surgeons during these procedures by helping them ensure complete removal of tumor tissue.
This fast-track designation was supported by findings from a phase 2 trial published in the Annals of Thoracic Surgery, which demonstrated that abenacianine was able to visualize the primary and metastatic tumor tissue during lung surgery, while being safe and well-tolerated.
Fast track designation is a process that expedites the development of a drug, facilitating its review for treating serious conditions and addressing unmet medical needs, according to the FDA’s website.
In this phase 2 trial, among 40 patients given abenacianine and undergoing standard-of-care surgical resection for suspected lung cancer, 17 (43%) patients experienced at least one clinically significant event, according to the release. The primary objective was to determine the number of patients who experienced at least one clinically significant event. This event was defined as the ability to locate challenging-to-find tumors, identify positive surgical margins or detect previously undetected tumors that could have been missed using conventional visual and palpation methods.
Patients were to receive an intravenous administration of 0.32 milligrams per kilogram of abenacianine at 12 to 36 hours prior to surgery. After dosing, patients were observed for up to two hours and were asked about possible treatment related side effects.
Patients were monitored for safety during hospitalization and after discharge, approximately 14 days post-surgery. Telephone assessments were conducted between 14- and 39-days post-surgery. Final safety assessments were made at the clinic or via telehealth between 19- and 39-days post-surgery. If no side effects require further follow-up, patients were to be released from the study.
Additionally, findings from a phase 2, multicenter VISUALIZE trial evaluated the efficacy and safety of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung. In 2025, enrollment for the phase 3 confirmatory, multicenter VISUALIZE-2 study will begin. This will allow patients who fit the criteria for treatment with abenacianine to have earlier access to the regimen.
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