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DECEMBER 5, 2024

FDA Grants Accelerated Approval to Bizengri for NSCLC and Pancreatic Adenocarcinoma

The FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the following:
advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy.

This is the first FDA approval of a