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BeOne Receives the US FDA Priority Review to  Tevimbra Combination for 1L Treatment of HER2+ GEA Cancers

Shots: FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…

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Jazz Pharmaceuticals to Highlight P-III (HERIZON-GEA-01) Trial Data on Ziihera (Zanidatamab-hrii) for Gastroesophageal Adenocarcinoma (GEA) at ASCO 2026

Shots: The P-III (HERIZON-GEA-01) trial assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as the 1L treatment in 914 adults with HER2+ locally advanced or metastatic GEA Ziihera + CT & Ziihera + Tevimbra + CT showed prolonged PFS with 35% risk reduction delivering mPFS of 12.4mos., with mOS of 24.4 & 26.4mos., respectively,…

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