According to a story from BioSpace, AstraZeneca and Merck released a joint announcement recently stating that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to olaparib (marketed at Lynparza) as a targeted therapy for pancreatic cancer. Olaparib was originally developed by AstraZeneca and other researchers. Olaparib belongs to a unique class of drugs called PARP inhibitors, and it is currently approved for the treatment of ovarian cancer.
About Pancreatic Cancer
Pancreatic cancer is an exceptionally deadly type of cancer that originates in the pancreas. This cancer is often fatal and it is rarely detected until after it has reached an advanced stage and begun to spread because it does not cause noticeable symptoms in the early stages. Risk factors include African American ancestry, old age, smoking, a diet rich in processed meat, meat cooked at high temperatures, or red meat, obesity, diabetes, family history, and chronic pancreatitis. Symptoms of pancreatic cancer may include jaundice, diabetes, depression, upper abdominal pain, constipation, appetite loss, and unexplained weight loss. Treatment may include surgery, chemo, and radiation therapy. Despite extensive treatment, the overall survival rate for pancreatic cancer is very poor; just five percent of patients are alive five years after diagnosis. To learn more about pancreatic cancer, click here.
About Orphan Drug Designation
Orphan Drug designation is reserved for treatments that are intended to treat rare diseases. A rare disease is defined as any condition that affects 200,000 people or less in the US. In addition, the drug must display potential advantages in either safety or effectiveness compared to currently available treatments, or it must fulfill a medical need that is currently unmet. Orphan Drug designation provides substantial benefits to the recipient company, such as tax breaks, the waiving of certain fees, and a seven year period of market exclusivity if the drug is approved.
Ongoing Research
Olaparib is currently being tested as a maintenance therapy for pancreatic cancer in a Phase 3 clinical trial. The drug is being tested as a monotherapy for patients who have metastatic pancreatic cancer that has not progressed after treatment with platinum chemotherapy. The data from this trial is expected to be released in early 2019.
