Prestige Bio's pancreatic cancer treatment gets US FDA fast-track designation
Ji-Hyun Lee
Mar 16, 2023 (Gmt+09:00)
Prestige Biopharma, a biopharmaceutical company in South Korea, announced on Thursday that their pancreatic cancer antibody drug, PBP1510 (Ulenistamab), has received fast-track designation from the US Food and Drug Administration.
This designation enables clinical development and application preparation for approval to proceed simultaneously, thereby shortening the time required for commercialization.
The company intends to be reviewed sequentially following the receipt of data from clinical stages 1 and 2a, which are currently underway in Europe and the US.
PBP1510 is a novel antibody drug that targets a protein found in pancreatic cancer. In 2020, it was granted orphan drug designation by both the US FDA and the Korean Ministry of Food and Drug Safety.