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Roche Wins FDA Approval For The First Diagnostic To Identify Biliary Tract Cancer Patients For HER2-Targeted Therapy With ZIIHERA

ロシュ、HER2標的治療向けの胆道がん患者を特定するための初の診断薬についてFDA承認を受ける

Benzinga ·  2024/11/25 01:28
  • The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.
  • There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis.
  • This approval represents a new indication for Roche's existing PATHWAY HER2 (4B5) test and expands its clinical utility by broadening the scope of patients who are eligible for HER2-targeted therapies.
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