West Lafayette, IN – May 19, 2025 – Hundreds of patients have benefited from the use of CYTALUX® (pafolacianine) injection during their lung and ovarian cancer surgeries since granted FDA approval. This number is growing rapidly. Today, On Target Laboratories is pleased to share that the results from the CYTALUX clinical trials have successfully translated into and been confirmed by real-world experiences.
The new findings were revealed in an article, titled “Real-world localization of cancer in lungs with a commercially available folate receptor-targeted fluorescent agent for intraoperative molecular imaging,” authored by Nicholas Baker, MD (now with West Virginia University Health System), Ryan Levy, MD and colleagues in the Department of Cardiothoracic Surgery at UPMC and the University of Pittsburgh School of Medicine. It was featured recently in the Journal of Thoracic and Cardiovascular Surgery Techniques. Full text can be found HERE.
The trial concluded that early post market experience with CYTALUX for cancer in the lung demonstrated a high rate of nodule localization. These early experiences further reinforce CYTALUX as an adjunct to surgical resection that may enhance the ability for surgeons to identify cancer that may have otherwise been missed.
“We’ve successfully shown that IMI with pafolacianine translates from clinical research to clinical practice,” said Dr. Baker. “This is an exciting development for the thoracic surgeon community, and we hope to see the incorporation of IMI into clinical practices continue to grow. The potential to improve outcomes for patients with lung cancers is promising.”
Results showed that in 28 percent (11/39) of patients, the primary lesion was not detectable under visual inspection with white light but was visualized using CYTALUX.
“These early results are promising and demonstrate the ability of this unique technology to aid in intraoperative localization of small cancers and lesions that may be more semi solid or ground glass lesions,” said Levy. “This facilitates our ability to successfully remove these cancers with adequate surgical margins in a way that maximally preserves lung tissue.”
Additional key findings include:
- Lesions as small as 5mm were detected
- All cases achieved negative margins based on real-time intraoperative margin assessment
- There were 3 patients (8 percent) with occult malignant lesions identified; all were removed via wedge resection
- 55 percent (6/11) of lesions detected only by pafolacianine were semi-solid Ground Glass Opacities (GGOs)
- Eleven metastatic cancers were identified. Final pathology most commonly demonstrated colon adenocarcinoma (5/11, 45.4 percent)
About On Target Laboratories, Inc.
On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University’s Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.
CYTALUX, the Company’s first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information and to view full Prescribing Information visit www.ontargetlabs.com and www.cytalux.com.