Roche (RHHBY) announced that the U.S. Food and Drug Administration has approved an expansion of the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test label to include biliary tract cancer (BTC). This test is now the first and only FDA-approved companion diagnostic to assess HER2-positive status and identify BTC patients eligible for treatment with Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii).
HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy. No approved and validated HER2 test existed to identify eligible BTC patients until the approval of this expanded label for the PATHWAY HER2 (4B5) test.
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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.