On Target Laboratories Announces FDA Approval of CYTALUX ™ (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery

On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancers and illuminates intraoperatively under near-infrared light.

“Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging,” said Dr. Janos L. Tanyi, MD, PhD, Associate Professor of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine and Investigator on the Phase 2 and 3 studies. “In the Phase 3 study, additional cancer was detected in 27% of patients, showing great promise in the ability of CYTALUX to help surgeons identify malignant lesions that may otherwise be missed during surgery.”

Ovarian cancer is the number one cause of gynecologic cancer death in the United States.  Cytoreductive surgery is a well-established treatment for ovarian cancer, however, a study showed that among patients reported to have undergone optimal cytoreduction, 40% were found to have measurable disease on 30-day postoperative imaging. CYTALUX serves as an adjunctive tool for surgeons to identify additional malignant ovarian cancer lesions that may have been missed by standard visual inspection and palpation, increasing the detection of more cancer during surgery.

Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and itching were reported during the administration of CYTALUX (see additional Important Safety Information below).

“This FDA approval is a significant milestone towards achieving On Target’s mission to make cancer visible during surgery so it can be removed more completely,” said Chris Barys, President and Chief Executive Officer of On Target Laboratories. “We are excited about the potential impact CYTALUX can have for patients in their fight against ovarian cancer.  Our goal is to make CYTALUX a standard of care for ovarian cancer surgery and we look forward to exploring the use of our technology for patients suffering from other cancers.”

CYTALUX received Priority Review and both Fast Track and Orphan designations from the FDA.  Additionally, CYTALUX is being investigated in cancer of the lung in a Phase 3 trial under Fast Track designation.