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Top Alliance Biosciences: Application Approved for Toripalimab as First-Line Therapy for HER2-Positive Urothelial Carcinoma
2 week ago /
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Author：小编
Top Alliance Biosciences is pleased to announce that its application for expanding the indication of toripalimab, co-developed with Rongchang Biopharmaceuticals, has been accepted by the National Medical Products Administration. The proposed new use is as a first-line treatment in combination with disitamab vedotin for patients diagnosed with locally advanced or metastatic urothelial carcinoma that expresses HER2. This milestone follows a successful multicenter, randomized, open-label, Phase III clinical trial with a positive drug control arm, demonstrating that the primary endpoints of progression-free survival and overall survival significantly surpassed the predefined superiority threshold.
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