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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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.