Taiho Pharmaceutical Co., Ltd. announced that it launched Solmack® Q-Arl D, a designated second-class OTC drug, in pharmacies and drugstores throughout Japan today, March 13, 2024. Solmack Q-Arl1 D is effective for diarrhea caused by overeating and overdrinking as well as diarrhea caused by getting chilled while asleep.
Solmack Q-Arl D
The Solmack series has steadfastly addressed issues such as the nausea caused by overeating, overdrinking, hangovers, and other unpleasant aftereffects of drinking too much for over four decades since its launch in 1979.
Solmack Q-Arl D is the second product in the Q-Arl series within the Solmack brand lineup, following Solmack Q-Arl S. Solmack Q-Arl D contains the antidiarrheal ingredient Loperamide Hydrochloride, the digestive enzyme Biodiastase 2000, and Lactomin, a type of lactic acid bacteria. These three active ingredients are effective for the symptoms of diarrhea.
According to a 2021 in-house survey of alcohol consumers2, the symptoms people associate with drinking alcohol were thirst (25.1%), flushed face/body (23.6%), headache (23.5%), body bloating (16.4%), and memory impairment (15.8%), followed by diarrhea (loose bowels, soft stool, etc.) at 15.7%. Additionally, when asked about symptoms actually experienced in the past year, diarrhea (loose bowels, soft stool, etc.) ranked highest, at 22.1%, indicating about one in five people had this experience. Solmack Q-Arl D supports people in such situations. The symptoms of diarrhea caused by overeating and overdrinking can occur anywhere. Since Solmack Q-Arl D comes in easy-to-take chewable tablets that can be taken without water, it provides convenient relief whenever and wherever diarrhea associated with overeating and overdrinking strikes.
Taiho Pharmaceutical will continue to create a chain of “smiles” by exploring people’s true needs and creating innovative products to meet such needs.
1 “Q-Arl” is a coined term combining “cure” and “alcohol.”
2 In-house survey
Survey entity: Taiho Pharmaceutical Co., Ltd.
Survey conducted by: Intage Healthcare Inc.
Survey period: April 2021
Sample size: 6,696 people (from a total of 10,099 screened, targeting respondents who drink alcohol at least once a year)
Survey method: Online questionnaire
Brand name |
Solmack® Q-Arl D |
Risk category |
Designated second-class OTC drug |
Active ingredients (1 day’s dose / 4 tablets) |
Loperamide Hydrochloride: 1 mg Biodiastase 2000: 90 mg Lactomin (Enterococcus faecalis): 20 mg |
Dosage and administration |
Chew or dissolve the following amount in the mouth. Discontinue use once diarrhea stops. Allow at least 4 hours between doses. Adults (15 years or older): Take two tablets, twice a day. Under 15 years old: Do not take. |
Indications |
Diarrhea caused by overeating/overdrinking, and diarrhea caused by getting chilled while asleep |
Suggested retail price |
12 tablets (6 doses): JPY 1,320 yen (1,200 excluding tax) |
Launch date |
March 13, 2024 |
Manufacturer |
Daisho Pharmaceutical Co., Ltd. |
Distributor |
Taiho Pharmaceutical Co., Ltd. |
This drug should only be used after consulting with a pharmacist or registered salesperson and carefully reading the precautions for use.
Taiho Pharmaceutical Co., Ltd. announced that the smoking rate among its employees has been reduced from 15% in 2020 to 0.3% in 2023*1 as a result of initiatives implemented since 2020 to encourage and support employees’ voluntary smoking cessation*2.
In February 2017, Taiho Pharmaceutical announced its Health Pledge*3, affirming its commitment to protecting the health of its employees, their families, and the surrounding community, reflective of the company’s awareness of, responsibility for, and close involvement with human life and its primary focus on oncology. In the ongoing efforts to promote smoking cessation, Taiho Pharmaceutical has added a new clause to its work regulations this January, prohibiting smoking during working hours. This change reflects the progress that has been made company-wide in cultivating a corporate culture where employees who smoke are encouraged to quit voluntarily, and their colleagues warmly support this effort. It has been determined that now is the appropriate time to update the work regulations. With this update, we reaffirm our commitment to fostering a healthy workplace and to each employee's health.
Our various initiatives, including smoking cessation programs, deemed effective in extending healthy life expectancy, have received external recognition. In November 2023, Taiho Pharmaceutical was honored with the Director-General of the Health Service Bureau, Ministry of Health, Labour and Welfare Excellence Award (Corporate Category) at the "12th Extend Healthy Life Expectancy Award" co-hosted by the Ministry of Health, Labour and Welfare and the Japan Sports Agency.
Guided by the corporate philosophy, "We strive to improve human health and contribute to a society enriched by smiles," Taiho Pharmaceutical regards its 'Human Capital' as a paramount business asset. Believing in this, we will continue to provide various forms of support aimed at achieving a smoking rate of zero, ensuring that our employees can work in a vibrant and open environment, and we will maintain our commitment to preserving our employees' health.
*1: As determined by a survey conducted in November 2023 of 2408 employees, with 7 current smokers, the company has attained a 0% smoking rate among executive and managerial personnel. *2: Please see Taiho Pharmaceutical's press releases:
From October 16, 2020,"Taiho Pharmaceutical Supports Employees' Efforts to Quit Smoking," and October 6, 2022,"Taiho Pharmaceutical Adds New Measures to Reduce Smoking Among Employees to Zero by 2023."
*3: Taiho Pharmaceutical's Health Pledge
2020 Initiatives:
・Subsidy for smoking cessation outpatient expenses (including online sessions)
・Sharing insights and strategies from employees who have successfully quit smoking
・Implementation of a comprehensive no-smoking policy during working hours
・Prohibited smoking in all laboratory and factory areas
・Non-smoking condition for new graduate hires and career hires
・Including smoking status as one of the factors considered for promotion to department managers
2021 Additional Initiatives:
・Financial support for the purchase of smoking cessation aids
・Health guidance for smokers (for those who wish to participate)
2022 Additional Initiatives:
・Conducting individual counseling sessions with smokers
・Implementation of a comprehensive no-smoking policy during working hours, including break times
・Including smoking status as one of the factors considered for promotion to management and administrative positions
・Including smoking status as one of the factors considered for continued post-retirement employment classification
2023 Additional Initiatives:
・Conducting tripartite interviews for smokers
・Delivering quit-smoking support messages with a handwritten signature from the president directly to smokers
2024 Regulation Revision:
・January: Incorporation of non-smoking during working hours into the work regulations
Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) announced today that the FGFR inhibitor “LYTGOBI® tablets 4mg” (generic name: futibatinib) has been listed on the National Health Insurance (NHI) reimbursement price list. The new product is scheduled for launch on September 7, 2023, in Japan.
LYTGOBI, discovered by Taiho, is an FGFR inhibitor. LYTGOBI binds covalently to FGFR 1, 2, 3 and 4, and inhibits FGFR-mediated signal transduction pathways selectively and irreversibly, resulting in reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations. Based on the results of the FOENIX-CCA2* phase 2 trial, LYTGOBI was approved in Japan in June 2023 for unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy.
*FOENIX-CCA2 trial: PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS Harboring FGF/FGFR Aberrations; FGFR Oral SElective Novel Inhibitor X [across] tumors
In September 2022, the U.S. Food and Drug Administration (FDA) approved LYTGOBI for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements. In July 2023, the European Commission (EC) granted conditional marketing authorization for LYTGOBI monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Taiho believes that LYTGOBI will make a positive contribution as a new treatment option for patients with biliary tract cancer.
Biliary tract cancer is a general term for cancer that develops in the biliary tract and is classified into bile duct cancer, gall bladder cancer, and papillary cancer, depending on the site of origin. Intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver, is included as biliary tract cancer. According to the National Cancer Center, the annual incidence of biliary tract cancer, including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and papillary cancer, is approximately 25,000 in Japan.1
FGFRs belong to a family of receptor-type tyrosine kinases involved in angiogenesis, wound healing and embryonic development. Fibroblast growth factors (FGFs) and their receptors (FGFR 1, 2, 3 and 4) are expressed on diverse cell types and regulate cell growth, survival, migration and differentiation. Recently, FGF/FGFR gene abnormalities have been reported in several types of cancer, and have attracted attention as candidate driver genes for cancer.
Product name |
LYTGOBI® tablets 4mg |
Generic name |
Futibatinib |
Indications |
Unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy** |
Dosage and administration |
Normally, for adults, oral administration in fasting condition of 20mg of futibatinib once daily. Dosage should be reduced based on the patient's condition. |
Date of manufacturing and |
June 26, 2023 |
Date listed in NHI reimbursement price listing |
August 30, 2023 |
Date of initial |
September 7, 2023 |
NHI reimbursement price |
JPY10,252.50 / tablet |
Packaging |
PTP packing: 35 tablets (5 tablets × 7) |
Manufacturer and distributor |
Taiho Pharmaceutical Co., Ltd. |
**Administer to patients harboring FGFR2 gene fusions confirmed by testing conducted by an experienced pathologist or laboratory. For the testing, an approved in vitro diagnostic product or medical device should be used.
1) Calculated based on National Cancer Institute Cancer Information Service, Cancer Statistics (National Cancer Registry). National Cancer Incidence Data (2016-2018) and Follow-up Survey Committee, Liver Cancer Study Group of Japan. Kudo M, Izumi N, Kubo S, Kunido N, Sakamoto T, et al. The 21st National Primary Liver Cancer Follow-up Study Report (2010-2011). Liver. 2020;61:645-691.
Taiho Pharmaceutical Co., Ltd. (hereafter “Taiho”) announced today that its partner, Servier (France) has received approval from the European Commission, of LONSURF® (trifluridine/tipiracil) in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have received two prior anti-cancer treatments including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.,
The approval by the European Commission is supported by data from the phase 3 SUNLIGHT trial for patients suffering from an advanced colorectal cancer who have already failed two prior chemotherapy regimens. The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.
Taiho remains committed in delivering new treatment options to patients and health care professionals around the world.
Colorectal cancer (CRC) is the third most common cancer worldwide,1,2 with over 1.9million people newly diagnosed with the disease in 2020,2 equating to 10% of the global cancer cases.1 Approximately 70% of CRC patients will eventually develop metastatic relapse3, and median overall survival in refractory mCRC is between 4-8 months.4 CRC is the second most common cause of cancer mortality, accounting for 930,000 deaths globally in 2020.2 The worldwide incidence of colorectal cancer is expected to exceed 3 million cases annually by 2040,5 and the number of deaths is predicted to increase by more than 70% to 1.6 million per year.5
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.
In 2015, Taiho and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier has been developing and commercializing LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Japan/Asia. LONSURF is already approved by the EC as monotherapy for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents; as well as metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.6
*LONSURF®
Generic name:Trifluridine/ tipiracil
Product Name in Japan:LONSURF® combination tablets T15, T20
Indications in Japan:
・Unresectable advanced or recurrent colorectal cancer
・Unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy
SUNLIGHT is a multinational, randomized, active-controlled, open-label two-arm Phase 3 trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil plus bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to assess trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of overall survival (OS). Key secondary endpoints were progression free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil used in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy.
The SUNLIGHT trial was conducted by Servier and Taiho Oncology, Inc. For more information on SUNLIGHT, please visit: https://clinicaltrials.gov/ct2/show/NCT04737187
SUNLIGHT:An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. (SUNLIGHT Study)
Founded to serve health, Servier is a global pharmaceutical group governed by a non-profit foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. As a world leader in cardiology, the Group’s ambition is to become a renowned, focused and innovative player in oncology by targeting hard-to-treat cancers. Servier is also involved in neuroscience and immune-inflammatory diseases to increase the pace of therapeutic innovation. To promote access to quality care for all, Servier offer a range of quality generic medicines covering most pathologies.
In all these areas, the Group include the patient voice at each stage of the life cycle of a medicine.
1: Digestive Cancers Europe. Prevalence of Colorectal Cancer. Available at: https://digestivecancers.eu/colorectal-cancer/prevalence-of-colorectal-cancer-prevalence/?menu_id=13873. Last accessed: June 2023
2: World Health Organization. International Agency for Research on Cancer. Colon factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/8-Colon-fact-sheet.pdf Last accessed: June 2023
3: Wang J., Li S., Liu Y., et al. Metastatic patterns and survival outcomes in patients with stage IV colon cancer: A population‐based analysis. Cancer Med. 2020. 9(1): 361–373
4: Tabernero J., Taieb J., et al. Trifluridine/tipiracil plus Bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design. Future Oncol. 2021.17(16): 1977–1985. Available at: https://www.futuremedicine.com/doi/full/10.2217/fon-2020-1238 Last accessed: June 2023
5: World Health Organization. International Agency for Research on Cancer. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Available at: https://www.iarc.who.int/news-events/global-burden-of-colorectal-cancer-in-2020-and-2040-incidence-and-mortality-estimates-from-globocan/#:~:text=The%20authors%20predict%20that%20by,an%20increase%20of%2073%25. Last accessed: June 2023
6: EMA. LONSURF: Summary of Product Characteristics. Available at : https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf Last accessed: June 2023
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Taiho Pharmaceutical Co., Ltd. announced today the launch of the third “Taiho Smile Support,” the company’s unique social contribution program. Under the program, Taiho Pharmaceutical will solicit project proposals on the theme of “Challenging Issues in the Field of Oncology” via its website from July 3 to September 30, 2023.
Taiho Smile Support is a social contribution program that supports organizations and individuals seeking to help solve various social issues in the field of oncology that cannot be solved by drugs alone. The program employs crowdfunding. If a selected organization or individual starts crowdfunding and is able to raise 50% of the amount needed to carry out the project, they will also receive matching funds from Taiho Pharmaceutical equal to 50% of the amount needed to carry out the project.
Taiho Smile Support: available only in Japanese
Through this program, Taiho Pharmaceutical aims to support the dreams of organizations and individuals who are working to address challenges in the field of oncology. In partnership with these organizations, individuals, and all of the people who support them via crowdfunding, Taiho Pharmaceutical seeks to build a world where the precious moments of everyday life keep flowing for people with cancer and their families.
Application period |
July 3 to September 30, 2023 |
Target theme |
Challenging Issues in the Field of Oncology |
Result announcement |
Late November 2023 |
Crowdfunding implementation period |
November 2023 to April 30, 2024 |
Matching funds disbursement |
Early June 2024 |
Project implementation period |
June 2024 to May 2025 |
Project implementation report |
Please submit a report to Taiho Pharmaceutical within three months after the project implementation is completed. |
Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) announced today that it has been granted approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market the FGFR inhibitor “LYTGOBI® tablets 4mg” (generic name: futibatinib) for unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy.
This approval is based on the data from the FOENIX-CCA2 trial. The FOENIX-CCA2 trial was a Phase 2 trial in 103 patients with locally advanced or metastatic unresectable intrahepatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. In the trial, patients who had received one or more prior lines of systemic therapy received LYTGOBI 20mg once daily until disease progression or unacceptable toxicity. The trial’s primary endpoint was objective response rate (ORR)* based on independent review.
*ORR (objective response rate) : Percentage of patients with objective evidence of response to anticancer treatment and other treatments
Results from the trial were published in the January 19, 2023 issue of The New England Journal of Medicine.1
Furthermore, a diagnostic device called the “OncoGuide™ NCC Oncopanel System” which detects FGFR2 gene fusions, co-developed with Sysmex Corporation, obtained additional approval for a partial change as a companion diagnostic to LYTGOBI in February 2023 in Japan.
Taiho believes that LYTGOBI will make a positive contribution as a new treatment option for patients with biliary tract cancer.
Biliary tract cancer is a general term for cancer that develops in the biliary tract and is classified into bile duct cancer, gall bladder cancer, and papillary cancer, depending on the site of origin. Intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver, is included as biliary tract cancer. According to the National Cancer Center, the annual incidence of biliary tract cancer, including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and papillary cancer, is approximately 25,000 in Japan.2
LYTGOBI (development code: TAS-120), discovered by Taiho, is an oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including biliary tract cancer, who were previously treated with chemotherapy or other therapies. LYTGOBI selectively and irreversibly binds to the ATP binding pocket of FGFR1-4, resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations. For details of the FOENIX-CCA2 trial, please refer to ClinicalTrials.gov (https://clinicaltrials.gov/ct2/home trial ID: NCT02052778).
FOENIX-CCA2 trial: PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS Harboring FGF/FGFR Aberrations; FGFR Oral SElective Novel Inhibitor X [across] tumors
The U.S. Food and Drug Administration (FDA) approved LYTGOBI for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements in September 2022.
European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization (CMA) of LYTGOBI for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
FGFRs belong to a family of receptor-type tyrosine kinases involved in angiogenesis, wound healing and embryonic development. Fibroblast growth factors (FGFs) and their receptors (FGFR1-4) are expressed on diverse cell types and regulate cell growth, survival, migration and differentiation. Recently, FGF/FGFR gene abnormalities have been reported in several types of cancer, and have attracted attention as candidate driver genes for cancer.
Product name | LYTGOBI® tablets 4mg |
Generic name | Futibatinib |
Indications | Unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy |
Dosage and |
Normally, for adults, oral administration in fasting condition of 20 mg of futibatinib once daily. Dosage should be reduced based on the patient's condition. |
In line with its mission of “shaping the advancement of healthcare,” which is defined in the “Sysmex Way,” the corporate philosophy of the Sysmex Group, Sysmex works to contribute to the development of healthcare and the healthy lives of people. Sysmex conducts integrated R&D, manufacturing and sales, and provides support services for its instruments, reagents and software for in vitro testing of blood, urine and other bodily fluids. Sysmex supplies its products to medical institutions in more than 190 countries and regions throughout the world. In recent years, Sysmex has been expanding its business in the life science domain, using proprietary technologies to create new testing and diagnostic value, realize healthcare that is optimized for individual patients, and help reduce patients’ burdens and enhance their quality of life.
URL: https://www.sysmex.co.jp/en/index.html
1 L. Goyal, F. Meric-Bernstam, A. Hollebecque, et al. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma, N Engl J Med 2023;388:228-39.
2 Calculated based on National Cancer Institute Cancer Information Service, Cancer Statistics (National Cancer Registry). National Cancer Incidence Data (2016-2018) and Follow-up Survey Committee, Liver Cancer Study Group of Japan. Kudo M, Izumi N, Kubo S, Kunido N, Sakamoto T, et al. The 21st National Primary Liver Cancer Follow-up Study Report (2010-2011). Liver. 2020;61:645-691.
Taiho Pharmaceutical Co., Ltd. (hereafter “Taiho”) announced today that its partner, Servier (France) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) , recommending the use of trifluridine/tipiracil (LONSURF®) in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
The CHMP’s positive opinion on LONSURF in combination with bevacizumab, in patients with refractory mCRC is based on clinical data from the SUNLIGHT trial, and will be referred to the European Commission (EC) for the final decision. This decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein.
Taiho remains committed in delivering new treatment options to patients and health care professionals around the world.
Colorectal cancer (CRC) is the third most common cancer worldwide,1,2 with over 1.9million people newly diagnosed with the disease in 2020,2 equating to 10% of the global cancer cases.1 Approximately 70% of CRC patients will eventually develop metastatic relapse3, and median overall survival in refractory mCRC is between 4-8 months.4 CRC is the second most common cause of cancer mortality, accounting for 930,000 deaths globally in 2020.2 The worldwide incidence of colorectal cancer is expected to exceed 3 million cases annually by 2040,5 and the number of deaths is predicted to increase by more than 70% to 1.6 million per year.5
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.
In 2015, Taiho and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier has been developing and commercializing LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Japan/Asia. LONSURF is approved by the EC as monotherapy for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents; as well as metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.6
*LONSURF®
Generic name:Trifluridine/ tipiracil
Product Name in Japan:LONSURF®combination tablets T15, T20
Indications in Japan:
・Unresectable advanced or recurrent colorectal cancer
・Unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy
SUNLIGHT is a multinational, randomized, active-controlled, open-label two-arm Phase 3 trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil plus bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to assess trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of overall survival (OS). Key secondary endpoints were progression free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil used in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy.
The SUNLIGHT trial was conducted by Servier and Taiho Oncology, Inc. For more information on SUNLIGHT, please visit: https://clinicaltrials.gov/ct2/show/NCT04737187
SUNLIGHT:An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. (SUNLIGHT Study)
Founded to serve health, Servier is a global pharmaceutical group governed by a non-profit foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. As a world leader in cardiology, the Group’s ambition is to become a renowned, focused and innovative player in oncology by targeting hard-to-treat cancers. Servier is also involved in neuroscience and immune-inflammatory diseases to increase the pace of therapeutic innovation. To promote access to quality care for all, Servier offer a range of quality generic medicines covering most pathologies.
In all these areas, the Group include the patient voice at each stage of the life cycle of a medicine.
1:Digestive Cancers Europe. Prevalence of Colorectal Cancer. Available at: https://digestivecancers.eu/colorectal-cancer/prevalence-of-colorectal-cancer-prevalence/?menu_id=13873. Last accessed: June 2023
2:World Health Organization. International Agency for Research on Cancer. Colon factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/8-Colon-fact-sheet.pdf Last accessed: June 2023
3:Wang J., Li S., Liu Y., et al. Metastatic patterns and survival outcomes in patients with stage IV colon cancer: A population‐based analysis. Cancer Med. 2020. 9(1): 361–373
4:Tabernero J., Taieb J., et al. Trifluridine/tipiracil plus Bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design. Future Oncol. 2021.17(16): 1977–1985. Available at: https://www.futuremedicine.com/doi/full/10.2217/fon-2020-1238. Last accessed: June 2023
5:World Health Organization. International Agency for Research on Cancer. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Available at: https://www.iarc.who.int/news-events/global-burden-of-colorectal-cancer-in-2020-and-2040-incidence-and-mortality-estimates-from-globocan/#:~:text=The%20authors%20predict%20that%20by,an%20increase%20of%2073%25. Last accessed: June 2023
6:EMA. LONSURF: Summary of Product Characteristics. Available at : https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf Last accessed: June 2023