Wednesday, Jazz Pharmaceuticals plc. (JAZZ) announced that the FDA has accepted and granted a Priority Review of the Biologics License Application or BLA for zanidatamab.
The drug is a human epidermal growth factor receptor 2 or HER2-targeted bispecific antibody intended to treat previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer.
The company said that the submission of their BLA is supported by results from Cohort 1 of the Phase 2b HERIZON-BTC-01 clinical trial of zanidatamab.
Furthermore, the company mentioned that the HERIZON-BTC-302 Phase 3 trial, which aims to assess the efficacy and safety of zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC, is currently ongoing and accepting participants.
The company stated that the FDA has set a target action date of November 29, 2024, under the Prescription Drug User Fee Act.
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