Zanidatamab BLA accepted by FDA for priority review

The US Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) submitted by Jazz Pharmaceuticals (Nasdaq: JAZZ) for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 29, 2024.

Zanidatamab is being developed by Jazz and Chinese firm BeiGene (Nasdaq: BGNE), under license agreements from Canada’s Zymeworks (TSX: ZYME), which first developed the molecule.