Regulators designated Aduro Biotech Inc.'s new combination of CRS-207 and GVAX Pancreas drugs a "breakthrough therapy," putting it on the fast track to U.S. Food and Drug Administration (FDA) approval. This means that instead of going through the standard approval process, which typically takes years, it could be only a matter of months before this much-needed therapy is available to patients.
The designation was based on data from an ongoing phase 2 trial of 93 patients with metastatic pancreatic cancer who did not respond to other treatments.
According to study results, patients who received the combination of GVAX Pancreas and CRS-207 cancer vaccines had better outcomes than those who received GVAX Pancreas vaccine alone.
The new immune system-boosting treatment’s breakthrough status means it could be on the fast track to FDA approval within a few months. Experts are hopeful that combination immunotherapy could help extend the lives of those with metastatic pancreatic cancer.
What is pancreatic cancer?
The pancreas is a digestive organ located behind the stomach and bounded by the liver, small intestine, and spleen. It secretes enzymes to break down different molecules in the food we ingest and aids in digestion. Pancreatic juices are released into the upper part of the small intestine which help the body to digest fats, carbohydrates and proteins.
As an endocrine gland, the pancreas secretes two hormones, insulin and glucagon, to regulate blood sugar levels during the course of the day. These hormones are released directly into the bloodstream, the former acting to lower blood sugar and the latter to raise it. Maintaining proper blood sugar levels is vital to the body – namely to our brain, liver and kidneys, so they can work appropriately.
How common is it?
According to the National Cancer Institute, upwards of 45,000 new cases of pancreatic cancers were reported in the United States last year. Almost 40,000 patients lost their lives to the disease. Although pancreatic cancer accounts for less than 3 percent of new cancer diagnoses each year, it is the fourth most frequent cause of cancer death for both men and women. Compared to other cancers, the survival rate of those diagnosed with pancreatic cancer is very low with a 5-year survival rate of about 5 percent.
This, in many ways, is due to the lack of preventative diagnostic tools available for this type of cancer. Unlike prostate or breast cancer, there is no annual test or biomarker that can be measured in order to ensure early diagnosis of the disease.
How is it diagnosed?
The exact cause of pancreatic cancer is still unknown, but certain risk factors like smoking, family history and chronic pancreatitis increase the risk of developing the disease.
Signs of pancreatic cancer usually do not present themselves until the disease is advanced, making it very difficult to diagnose. Some symptoms include:
- Upper abdominal pain
- Yellowing of skin and whites of eyes
- Loss of appetite
- Weight loss
- Depression
- Blood clots
How is it treated?
Pancreatic cancer is one of the most challenging cancers because it is difficult to diagnose, responds poorly to treatment, and spreads quickly to surrounding organs like the stomach and small intestines. Treatment of pancreatic cancer may include surgery, chemotherapy and/or radiation. Depending on the size of the tumor, surgery may remove just a cancerous mass from the pancreas or part of the pancreas itself.
Dr. David B. Samadi is the Chairman of the Department of Urology and Chief of Robotic Surgery at Lenox Hill Hospital in New York City. He is a board-certified urologist, specializing in the diagnosis and treatment of urological disease, with a focus on robotic prostate cancer treatments. Dr. Samadi joined Fox News Channel in 2009 as a medical contributor. To learn more please visit his websites RoboticOncology.com and SMART-surgery.com. Find Dr. Samadi on Facebook.
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