Roche Wins FDA Approval For The First Diagnostic To Identify Biliary Tract Cancer Patients For HER2-Targeted Therapy With ZIIHERA
Roche Wins FDA Approval For The First Diagnostic To Identify Biliary Tract Cancer Patients For HER2-Targeted Therapy With ZIIHERA
羅氏公司獲得FDA批准，首個診斷工具可識別膽道癌患者，適用於HER2靶向治療ZIIHERA。
- 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.
- PATHWAY HER2 (4B5) 測試有助於識別之前接受過治療的、不可切除或轉移性 HER2 陽性膽道癌 (BTC) 患者，這些患者可能有資格接受 ZIIHERA 治療。
- 目前對於BTC患者來說，選擇很少，因爲大多數病例在診斷時已處於晚期。
- 此次批准爲羅氏現有的PATHWAY HER2 (4B5)檢測提供了新的適應症，並通過擴大符合HER2靶向治療資格的患者範圍，擴展了其臨床效用。
譯文內容由第三人軟體翻譯。
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