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Tecentriq fails urothelial carcinoma trial but beneficial

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.03.04 05:50:37

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Roche voluntarily withdrew UC indication from the FDA last year... indication still valid in Korea



Although the conditional clinical trial failed for Roche¡¯s cancer immunotherapy ¡®Tecentriq,¡¯ experts in Korea decided to recognize Tecentriq¡¯s benefit for ¡®patients with locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy¡¯ and maintain the indication as it is unethical to reorder clinical trials when these patients have no other alternatives.

According to the minutes of the Central Pharmaceutical Affairs Council meeting that was held on November 28th last year which was recently disclosed by the Ministry of Food and Drug Safety, the CPAC members decided to recognize the benefit of the therapeutic confirmatory clinical trial results on Tecentri

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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