Earlier this week, the United States Food and Drug Administration (FDA) announced its approval for a novel drug that can be used to make ovarian tumors glow. The drug was developed in order to assist surgeons in identifying and removing tumors and cancerous cells during surgical cancer removal. The drug was designed and developed at Purdue University and is being released for market by the biotech company On Target Labs.
According to the Centers for Disease Control, ovarian cancer is the second most common gynecological cancer in the United States. Ovarian cancer occurs when cancerous cells invade the ovaries, multiply quickly, and destroy healthy tissue. Ovarian cancer is survivable if treated correctly. Treatment usually involves chemotherapy and surgery to remove the tumor and cancerous cells. However, cancer surgery can be complicated by multiple challenges that include localizing and identifying tumors and ensuring all cancerous cells have been removed. Because of these challenges, the novel drug called Cytalux was developed to mark cancer cells with a fluorescent tag that allows the cells to glow during surgery.
The drug is delivered via an intravenous injection 1 to 9 hours prior to surgery. The drug attaches to the cancer cells which allows surgeons to easily visualize the cancer. Dr. Philip Low, a professor of chemistry at Purdue University who helped develop the drug, said that when the drug is administered and the surgeon turns on the near-infrared light, the cancer cells, “light up like stars against a night sky.” He also added, “It seems to me that future [cancer removal] surgeries are going to very heavily rely on this technology.”
The FDA-approval of the drug is based on a successful Phase 3 clinical trial that tested the drug. In the study, patients with ovarian cancer underwent surgery to remove the cancer. It was found that in 109 patients with ovarian cancer, surgeons were able to easily and accurately identify and remove the primary tumor. Importantly, the surgeons intraoperatively identified additional cancer not originally planned for resection in a statistically significant number of patients. Lastly, there were no serious drug-related adverse events. The FDA-approval of the drug is a significant milestone in cancer treatment and will help to significantly prevent ovarian cancer related deaths.