Release Date: 25-Sep-2021
US FDA has allowed LP-184 Orphan Drug Designation for the treatment of pancreatic cancer. LP-184 is a small molecule drug candidate and next generation alkylating agent that specially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair paths. LP-184 is being established for numerous targeted indications in cancer, including pancreatic cancer.
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.
Pancreatic cancer is the fourth foremost cause of cancer deaths in the U.S. with a 5 year survival rate of 7.9% and a 10-year survival rate of just 1%. A research estimates that for pancreatic cancers there are about 490,000 thousand fresh cases globally, with over 62,000 occurring in North America annually.