Ulenistamab Fast Tracked for Advanced/Metastatic Pancreatic Cancer

The Food and Drug Administration (FDA) has granted Fast Track designation to PBP1510 (ulenistamab) for the treatment of unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least 1 prior line of therapy.

Ulenistamab targets pancreatic adenocarcinoma upregulated factor, a tumor-specific protein that has been found to be overexpressed in pancreatic cancer cells.

The investigational drug is currently being evaluated in a global, two-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.

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.