Illuminating Cancer Cells During Surgery: A Worthy Olympus Investment
What if you could highlight tumors while the surgeon operates? That’s the idea behind CYTALUX® (pafolacianine), an imaging agent administered intravenously before surgery to help surgeons identify malignant and non-malignant lesions in adult patients with known or suspected lung cancer and ovarian cancer.1 On November 16, 2023, Olympus Innovation Ventures (OIV) announced its participation in the $30M Series C funding round to help West Lafayette, Ind. based On Target Laboratories (OTL). The team is working to accelerate commercialization of their novel compound—used in conjunction with near infrared surgical imaging devices.
CYTALUX is a molecular imaging agent with U.S. regulatory approval that illuminates lung and ovarian cancer as an adjunct during surgery, designed to improve surgeon’s ability to detect cancerous tissue.
Lighting up lesions
On Target Laboratories was founded in 2010, according to its website. Their "small molecular technology” is 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. Their solution includes a near-infrared dye and targeting molecule that binds to receptors overexpressed on cancer cells with the goal of making cancer more visible in the OR.
CYTALUX received U.S. regulatory approval of its New Drug Application (NDA) in November 2021 for ovarian cancer, and a supplemental NDA for lung cancer in December 2022. In August 2023, On Target Laboratories was also granted a new technology add-on payment for CYTALUX.
Important Safety Information
Adverse reactions including nausea, vomiting, abdominal pain, flushing, allergic reaction, elevation in blood pressure, indigestion, and chest discomfort were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.
Risk of Misinterpretation
Errors may occur with the use of CYTALUX. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, lungs, and inflamed tissue.
CYTALUX may cause fetal harm when administered to a pregnant woman. There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Contact your healthcare provider with a known or suspected pregnancy.
Folate Supplementation Usage
Folic acid may reduce the detection of cancerous tissue with CYTALUX. Patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX.
The most common side effects of CYTALUX reported in clinical trials were nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), allergic reaction (2%), elevation in blood pressure (1%), indigestion (1%), and chest discomfort (1%) during administration.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CYTALUX. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See full Prescribing Information for more details.
1. CYTALUX [package insert.] Grand Rapids, MI: Grand River Aseptic Manufacturing; 2022.