TS-1 Approved as Adjuvant Therapy for High-Risk Breast Cancer in Japan
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On November 24, 2022, Taiho Pharmaceutical Co., Ltd. announced that the oral anticancer agent TS-1 (Teysuno / S-1) has received approval in Japan for an additional indication: adjuvant treatment for patients with hormone receptor-positive (HR+), HER2-negative, high-risk early breast cancer.
Clinical Evidence: POTENT Trial
The approval is based on the results of the POTENT Phase 3 clinical trial, which involved 1,959 patients with HR+/HER2- early breast cancer. The trial compared two adjuvant strategies:
- Standard Endocrine Therapy for 5 years.
- Standard Endocrine Therapy (5 years) plus TS-1 for 1 year.
Key Findings
The trial met its primary endpoint, demonstrating a clinically significant improvement in invasive disease-free survival (iDFS) for patients receiving the combination of endocrine therapy and TS-1. The safety profile observed was consistent with previous reports for TS-1, with no new major safety concerns identified in this patient population.
Future Outlook
Taiho Pharmaceutical emphasized its commitment to providing TS-1 as a new treatment option to help improve outcomes and provide better quality of care for breast cancer patients.
Source: Taiho Pharmaceutical Press Release - TS-1 Approval for Breast Cancer
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