FDA granted fast track designanation for Ulenistamab (PBP1510) in PDAC

CAR-T Digest - August 2020

March 21, 2023: Ulenistamab (PBP1510) (IV)/ Pancreatic Cancer/ Prestige Biopharma: US FDA granted fast track designation

Prestige Biopharma received a fast-track designation from the US FDA for PBP1510 for the treatment of unresectable or metastatic pancreatic adenocarcinoma (PDAC)
PBP1510: Inhibits PAUF overexpression in pancreatic cancer
- Phase 1/2 trial (NCT05141149) progressed on at least one previous line of chemotherapy for locally advanced/metastatic disease administered with PBP1510 of 1mg/kg to 15mg/kg with or without Gemcitabine
This FDA Fast Track designation for PBP1510 represents a promising advancement in the treatment of pancreatic cancer