The following can be used to answer questions. FDA's treatment IND regulations offer a mechanism that allows drug developers to provide earlier and wider access to investigational therapies for patients with immediately life- threatening or otherwise serious diseases for which there is no satisfactory alternative treatment, while review of the new drug application for the same indication is completed. About 27,000 people in the United States were diagnosed with pancreatic cancer in l994.
Pancreatic cancer is generally asymptomatic until late in the course of the disease.
It is among the most difficult cancers to treat and is rarely curable. FDA authorized the treatment IND for gemcitabine to provide a promising treatment of locally advanced or metastatic pancreatic cancer. Patients may have had either one prior chemotherapy regimen or none. No therapies have been approved specifically for this disease. A preliminary review by FDA of two clinical trials of gemcitabine suggests that it may have some effectiveness in the treatment of this disease.