Table 1.
Years | Events |
---|---|
1957 | (i) Synthesis of 5-FU and discovery of its antitumor activity by Dushinsky et al. (3). |
1967 | (ii) Synthesis of FT by Hiller et al. (11) at the Latvian Institute of Synthesis, USSR |
June 1969 | Encounter with FT (Futraful®): Y. Kobayashi, the President of Taiho met with Blokhin the President Cancer Research Center, USSR Academy of Medical Science |
December 1969 | Introduction of FT by Taiho Pharmaceutical Co., Ltd |
1970 | Development of FT from the intravenous to oral agent by Kimura, Fujii and Taguchi |
1976 | (iii) Invention by Fujii et al. (16) of UFT® (oral combination drug), FT:Ura =1:4 |
1984 | Discovery of an inhibitor for 5-FU catabolic enzyme, CDHP by Tatsumi et al. (17) |
May 1987 | Discovery of Oxo that reduces 5-FU-induced gastrointestinal toxicities by Shirasaka et al. (18) |
November 1990 | Establishment of the S-1 project by Y. Kobayashi |
January 1991 | (iv) Invention of S-1 by Shirasaka et al. (19) S-1, FT:CDHP:Oxo =1:0.4:1 |
March 1991 | Onset of preclinical studies |
November 1992 | Onset of Phase I clinical trials |
March 1994 | Onset of Phase II clinical trials |
November 1997 | NDA of S-1 for gastric cancer |
January 1999 | Approval of S-1 (TS-1®) for gastric cancer through the priority review system (20,21) |
April 2001 | Approval of S-1 for head and neck cancer (22) |
December 2003 | Approval of S-1 for colorectal cancer (23,24) |
December 2004 | Approval of S-1 for non-small cell lung cancer (25) |
November 2005 | Approval of S-1 for breast cancer (26) |
August 2006 | Approval of S-1 for pancreatic cancer (27) |
August 2007 | Approval of S-1 for biliary tract cancer (28) |
2008 | Phase III studies of S-1 (29,30) |
FT, tegafur; CDHP, 5-chloro-2,4-dihydroxypyridine; Oxo, potassium oxonate; NDA, new drug application.