Jazz Pharmaceuticals Presents Groundbreaking HER2 Biliary Tract Cancer Data Ahead of FDA Decision

1. Priority Review: Zanidatamab has been granted priority review by the FDA for the treatment of HER2-positive metastatic biliary tract cancer (BTC).
2. First HER2-Targeted Treatment: If approved, zanidatamab will be the first HER2-targeted treatment specifically indicated for patients with HER2+ locally advanced or metastatic BTC.
3. Clinical Trial Results: The Phase 2b HERIZON-BTC-01 clinical trial demonstrated a confirmed objective response rate (cORR) of 41.3% in previously treated patients with unresectable, locally advanced, or metastatic HER2-positive BTC.
4. ASCO Presentation: The data from the trial was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023 and published in *The Lancet Oncology*.
5. PDUFA Date: The target action date for the FDA decision is set for November 29, 2024.
6. Unmet Need: The priority review designation highlights the critical need for new treatment options for patients with HER2-positive BTC, a disease with a poor prognosis.
7. Future Presentations: Additional long-term follow-up data from the Phase 2b HERIZON-BTC-01 trial will be presented at the upcoming ASCO Annual Meeting 2024.