FDA grants ONIVYDE fast-track designation for first-line combination therapy for metastatic pancreatic cancer

Epson announced that the U.SFood and DrugadministrationAdministration (
FDA) has granted fast-track designations for its Ilition lipids (ONIVYDE) for use in conjunction with 5-fluoruric preurea/folate acid (5-FU/LV) and O'Sullivan (OX) for previously untreated, unremovable locally metastatic and removable pancreatic catheterized adenocarcinous cancer (PDD)Photo Source:FDA's Fast Track Program aims to promote development, speed up the review of drugs that treat serious diseases and have the potential to meet unmet medical needsThe combination of ONIVYDE and 5-fluorourea/folate (5-FU/LV) has been approved in the United States and Europe for the treatment of metastaticpancreatic cancerpatients based on gisitabinthethetherapyHoward Mayer, Executive Vice President, Ipson Research and Development,, said, "With ONIVYDE's approval for metastatic pancreatic cancer, we remain committed to understanding the needs of pancreatic cancer patients and working to improve survival rates"
" As we continue to recruit more patients for Phase 3 NAPOLI-3 clinical studies, we look forward to working closely with the FDA to apply ONIVYDE to more pancreatic cancer patients at earlier stages of the disease"
pancreatic cancer is a rare and fatal disease, accounting for about 3% of all cancers and 7% of all cancer deaths More than half of the 57,600 pancreatic cancer patients in the United States were metastatic pancreatic cancer, with a total five-year survival rate of 3%