The US Food and Drug Administration (FDA) has granted fast track designation to ulenistamab (PBP1510) for the treatment of unresectable or metastatic pancreatic adenocarcinoma that has relapsed after and/or is refractory to at least 1 prior line of therapy.
Ulenistamab targets PAUF, a tumor-specific protein that is overexpressed in pancreatic cancer cells.
The investigational drug is currently being evaluated in a global, 2-part, phase 1/2a clinical trial (ClinicalTrials.gov Identifier: NCT05141149) as monotherapy and in combination with gemcitabine. Preclinical studies have suggested synergistic antitumor activity when ulenistamab is combined with gemcitabine.
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The FDA’s fast track designation is granted to therapies that are meant to treat serious conditions and allows for expedited review in order to bring new treatments to patients as quickly as possible.
Reference
Prestige Biopharma receives FDA Fast Track designation for PBP1510 in the treatment of pancreatic cancer. News release. Prestige Biopharma. March 21, 2023. https://www.businesswire.com/news/home/20230320005695/en/Prestige-Biopharma-Receives-FDA-Fast-Track-Designation-for-PBP1510-in-the-Treatment-of-Pancreatic-Cancer.
This article originally appeared on MPR
