(GIST) Taiho Pharmaceutical Submits Manufacturing and Sales Approval Application for TAS-116
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On September 14, 2021, Taiho Pharmaceutical Co., Ltd. submitted a manufacturing and sales approval application to Japan's Ministry of Health, Labour and Welfare for HSP90 inhibitor TAS-116 for gastrointestinal stromal tumors (GIST) that progressed after chemotherapy.
This application was based on results from the CHAPTER-GIST-301 Phase III clinical trial, which compared the efficacy and safety of TAS-116 versus placebo in previously treated GIST patients. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), safety, and quality of life. The trial was also conducted in Japan, enrolling 81 patients aged 20 years or older with previously treated GIST.
The clinical trial results demonstrated a significant extension in the primary endpoint PFS. No additional adverse events were observed in the safety assessment. The trial results were announced at the American Society of Clinical Oncology (ASCO) in June 2021.
TAS-116 is a compound developed by Taiho Pharmaceutical Co., Ltd. By inhibiting HSP90, it disrupts and reduces proteins such as KIT, PDGFRA, HER2, and EGFR that are associated with cancer growth and survival, demonstrating anti-tumor effects.
Source: https://www.taiho.co.jp/release/2021/20210914.html
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