News Release


 

Anticancer Agent TS-1 Combination OD Tablets T20, T25 to Be Launched in Japan (21/06/2013)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced today, that the additional formulation TS-1 combination OD tablets T20, T25 (hereafter, "the drug") of the anticancer agent TS-1 (nonproprietary name: tegafur, gimeracil, oteracil potassium combination) had received a National Health Insurance (NHI) reimbursement price listing. The drug is scheduled for launch in Japan on June 27.

The drug is the world's first anticancer agent in orally disintegrating tablet form that can be ingested without water since it quickly disintegrates upon contact with saliva in the mouth. The drug was developed in order to meet the needs of the many patients who have difficulty swallowing capsules or whose water intake is being restricted. The tablets are dry-coated to contain the active ingredients of the anticancer agent in the inner core, coated with an outer shell. The coating has the dual purpose of preventing the active ingredients from leaking out before administration while allowing quick disintegration in the mouth.

In addition to the existing combined capsules and combined granulated form, the drug provides a third option that can be chosen in accordance with each patient's needs. This option will improve the treatment compliance of patients and will lead to better treatment outcomes.

Taiho Pharmaceutical expects to further contribute to patients and medical professionals with the addition of the OD tablets.

About TS-1
A member of the fluoropyrimidine class of chemotherapeutic agents, TS-1 is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anticancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU in the liver; and oteracil (Oxo), which decreases 5-FU phosphorylation in the gastrointestinal tract.

Developed as a gastric cancer treatment, TS-1 was first approved in Japan in 1999 and has become a standard of care for the treatment of gastric cancer. TS-1 was subsequently approved in Japan for six additional indications: for the treatment of colorectal, head and neck, non-small cell lung, and inoperable or recurrent breast, pancreatic, and biliary tract cancers. TS-1 is also approved for patients with gastric cancer in 7 countries* in Asia, and in 15 European countries.*
*As of May 15, 2013.

About dry-coated orally disintegrating tablets
The dry-coating forms an outer shell that is durable yet readily disintegrates. By containing the active ingredient of the anticancer agent in an inner core, the tablet ensures that the active ingredient will not leak out before administration, while at the same time allowing the tablet to disintegrate quickly once placed inside the mouth.

Product Summary

Brand name TS-1 Combined OD Tablets T20, T25
Nonproprietary name Tegafur, gimeracil, oteracil potassium combination drug
Indications & Efficacy Gastric cancer, colorectal cancer, head and neck cancers, non-small-cell lung cancer, inoperable or recurrent breast cancer, pancreatic cancer, and biliary tract cancer
Use & Dosage Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area. TS-1 is administered twice daily, after breakfast and after the evening meal, for 28 consecutive days, followed by a 14-day rest. This is regarded as one course of the regimen.
 Body surface area (m2)     Initial dose (tegafur equivalent)
              < 1.25                         40 mg each time
    1.25 - < 1.5                           50 mg each time
 ≥ 1.5                                        60 mg each time
The initial dose can be decreased or increased according to the patient's condition. The doses are staged thus: 40 mg, 50 mg, 60 mg, and 75 mg. If no drug-induced abnormalities in laboratory findings (hematological tests, liver and renal function tests) and no gastrointestinal symptoms occur, i.e., the drug is not problematic in terms of safety, and it is decided to increase the dose, the initial dose can be increased one stage, with an upper limit of 75 mg. It can also be decreased by one stage, and the lower limit is 40 mg.
Date of manufacturing and marketing approval February 15, 2013
Date listed in NHI reimbursement price listing June 21, 2013
Date of initial marketing in Japan June 27, 2013
Packaging TS-1 Combined OD Tablets T20 PTP Packaging: 56 tablets (14 tablets x 4 sheets) 140 tablets (14 tablets x 10 sheets)
TS-1 Combined OD Tablets T25 PTP Packaging: 56 tablets (14 tablets x 4 sheets ) 140 tablets (14 tablets x 10 sheets )
NHI reimbursement price TS-1 Combination OD Tablets T20: 675.60 yen
TS-1 Combination OD Tablets T25: 812.80 yen
Manufacturing Distributor Taiho Pharmaceutical Co., Ltd.

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