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
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.