Therapeutic Response

v::NRG1 status confers therapeutic sensitivity to Zenocutuzumab in patients with Pancreatic Adenocarcinoma.

Statements

Source and description

Bizengri (zenocutuzumab-zbco) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The package insert notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).