In November 2021, a cancer treatment agent called Cytalux was approved by the US Food and Drug Administration (FDA). Between 22,000 and 24,000 women are diagnosed with ovarian cancer each year in the United States. Oncologists are hopeful that this new treatment can help many more of them survive.
What Is Cytalux?
Cytalux is the brand name for an optimal imaging agent called pafolacianine. This agent is designed for use during surgical procedures to remove part or all of the patient’s cancerous tissue. Cytalux binds to cancer cells and then turns fluorescent during the operation. This allows surgeons to find and remove ovarian cancer lesions during surgery more easily.
What Happens When a Patient Takes Cytalux?
Ovarian cancer patients often have an excess of folate receptors, which are a cell membrane protein. After being administered through injection, Cytalux seeks out the folate receptors and binds to them. The agent builds up a strong presence within the cancer cells, and the fluorescent effect makes the cancer cells glow. Tumors that would otherwise remain hidden become highly visible.
Along with making it easier to remove all cancerous cells, Cytalux allows surgeons to make sure all healthy tissue is left unharmed during the surgery. This technology is very exciting, as no similar fluorescent imaging agent has ever been approved by the FDA.
Side Effects of Cytalux
The FDA has identified several common side effects of Cytalux, including:
- Nausea
- Vomiting
- Abdominal pain
- Flushing
- Itching
- Dyspepsia
- Hypersensitivity
Fortunately, most of the common side effects seem to be relatively mild at this point.
Clinical Trial Process
Researchers tested Cytalux for safety and effectiveness in a series of clinical trials. The University of Pennsylvania was one of the main trial sites, as researchers there were already testing several other agents at the Precision Surgery Center. Additionally, Precision Surgery Center researchers have been working to develop multiple other targeted imaging technologies since the center was founded in 2015.
The study evaluated the response in 134 women who were diagnosed with ovarian cancer or who had a high clinical suspicion of ovarian cancer and were scheduled for surgery. The women ranged in age from 33 to 81 years old. Of these, 26.9 percent had at least one cancer lesion that was detected after taking Cytalux but was not detected under previous examinations.
How Have Surgeons Handled Ovarian Cancer Surgeries in the Past?
Prior to the approval of this drug, surgeons were limited in their ability to identify and remove cancer lesions. Three main methods have been used up until recently:
- Preoperative imaging – Imaging systems like MRI and X-ray CT are used to observe the ovaries and attempt to identify all cancerous lesions.
- Visual inspection – Surgeons survey the cancer site visually under normal light conditions, without the use of any visual aids.
- Touch – Examining the tumor with their hands to see if they can identify any cancer lesions by touch.
How Cytalux Could Help More Patients Survive Ovarian Cancer
Surgically removing as much of a tumor as possible is known as debulking. Several studies have shown that effective debulking is one of the most reliable ways to increase ovarian cancer survival rates. Because there are very rarely symptoms in the early stages, the majority of ovarian cancer diagnoses occur once the cancer has become advanced and a large tumor has already formed. The more of the tumor that can be removed, the more likely the patient is to survive.
Most ovarian cancer is treated through surgery and chemotherapy. In some cases, surgeons can remove the visible lesion, but hidden cancerous tissue is common in ovarian and other forms of cancer. These undiscovered cancer cells could potentially spread for months before being identified, all while the patient believes they are cancer-free. But if 100 percent of all cancer cells can be identified and removed, the patient will likely have a longer and more comfortable life.
Could Cytalux be Used to Fight Other Cancers?
At this point, Cytalux is only approved for use in ovarian cancer patients. However, University of Pennsylvania associate professor of obstetrics and gynecology Janos L. Tanyi is optimistic that the drug could eventually be adapted for use against other cancers. In an interview with the Philadelphia Inquirer, Dr. Tanyi said that he believes other cancer types that have folate receptors could potentially be targeted with Cytalux as well.
Additionally, the University of Pennsylvania is currently in Phase 3 trials of using Cytalux to treat lung cancer. According to Dr. Tanyi, the university’s findings up until this point indicate that the drug could potentially be used in the same way for lung cancer.