According to an article from kait8.com, the pharmaceutical company Yisheng Biopharma announced that YS-ON-001, a leading candidate for the company, received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This is not the first time that YS-ON-001 was given the designation status; it has also received for treating hepatocellular carcinoma, the most common type of liver cancer.
Pancreatic cancer is one of the most dangerous types of cancer. This is because it rarely causes any symptoms until it has metastasized and reached an advanced stage. This is a dangerous feature that pancreatic cancer shares with several other types. By this time, cancer is far more difficult to treat and becomes less responsive to treatment. When symptoms do appear, they include back or abdominal pain, yellow skin, loss of appetite, weight loss, and dark urine. People that are obese, are diabetic, eat large amounts of red meat, and smoke tobacco are at an increased risk of developing pancreatic cancer. Genetic conditions are a factor in a small percentage of cases. Despite treatment with surgery, radiation, and chemotherapy, outcomes are generally poor for pancreatic cancer; 5 year survival rate is only 5 percent. To learn more about this form of cancer, click here.
Orphan drug designation is a regulatory certification intended to incentivize the development of drugs to treat rare conditions. A drug can only receive Orphan Drug Designation if it meets certain criteria. It must treat a condition that is considered rare, and must also offer a major improvement in treatment effectiveness or satisfy a medical need that is not being met by currently available treatments. The designation helps streamline the trials process and also waives certain fees that the company would normally pay; additionally, it offers a period of seven year market exclusivity if the drug successfully makes it through testing and reaches approval.
The extremely poor five year survival rate for pancreatic cancer highlights the desperate need for more effective treatments. YS-ON-001 has the potential to be an answer to that need. It functions as a biologic immunomodulator that harnesses the body’s own immune system in order to attack tumors. In animal studies, the product was able to have a significant impact on tumors in a variety of different organs, signaling its potential to treat a great number of cancer types.