(Breast Cancer) Taiho Submits Additional Application for TS-1 as Adjuvant Chemotherapy
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- February 22, 2022
- 1 min read
On February 14, 2022, Taiho Pharmaceutical Co., Ltd. submitted an additional application to Japan's Ministry of Health, Labour and Welfare (MHLW) for the oral anticancer drug TS-1 as adjuvant chemotherapy following breast cancer surgery.
Approximately 95,000 new female cancer cases are diagnosed annually in Japan, of which approximately 75% are hormone receptor (HR)-positive and HER2-negative breast cancer. Standard post-surgical treatment for early-stage patients includes drug therapy and post-operative endocrine therapy in addition to surgery.
This application is based on results from the POTENT Phase 3 clinical trial, which demonstrated that 1 year of TS-1 combined with 5 years of endocrine therapy effectively suppressed disease recurrence in HR+, HER2-negative breast cancer patients. Compared to the control arm, invasive disease-free survival (IDFS) was significantly extended, and the safety profile was consistent with existing safety data.
Furthermore, this combination regimen received MHLW approval in March 2011 as post-operative therapy for HR+, HER2-negative breast cancer patients, classified under Advanced Medical Care Category B.
Taiho Pharmaceutical stated its commitment to obtaining approval to provide breast cancer patients with a new treatment option.
Source: https://www.taiho.co.jp/release/2022/20220214.html
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