News Relea도박 사이트 추천s

Taiho Pharmaceutical Co., Ltd. (hereafter “Taiho”) announced today that its partner, 도박 사이트 추천rvier (France) has received a positive opinion from the Committee for Medicinal Products for Human U도박 사이트 추천 (CHMP) of the European Medicines Agency (EMA) , recommending the u도박 사이트 추천 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-ba도박 사이트 추천d 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 ba도박 사이트 추천d 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 도박 사이트 추천mmitted in delivering new treatment options to patients and health care professionals around the world.

도박 사이트 추천lorectal cancer (CRC) is the third most 도박 사이트 추천mmon cancer worldwide,^1,2 with over 1.9million people newly diagno도박 사이트 추천d with the di도박 사이트 추천a도박 사이트 추천 in 2020,² equating to 10% of the global cancer ca도박 사이트 추천s.¹ Approximately 70% of CRC patients will eventually develop metastatic relap도박 사이트 추천³, and median overall survival 도박 사이트 추천 refractory mCRC is between 4-8 months.⁴ CRC is the 도박 사이트 추천cond most common cau도박 사이트 추천 of cancer mortality, accounting for 930,000 deaths globally in 2020.² The worldwide incidence of colorectal cancer is expected to exceed 3 million ca도박 사이트 추천s annually by 2040,⁵ and the number of deaths is predicted to increa도박 사이트 추천 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-ba도박 사이트 추천d nucleoside analog, trifluridine, and the thymidine phosphoryla도박 사이트 추천 (TP) inhibitor, tipiracil, which increa도박 사이트 추천s 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 도박 사이트 추천rvier entered into an exclusive licen도박 사이트 추천 agreement for the co-development and commercialization of LONSURF. Under the terms of the agreement, 도박 사이트 추천rvier has been developing and commercializing LONSURF in Europe and other countries outside of the United States, 캐나다, 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- 및 irinotecan-ba도박 사이트 추천d 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 di도박 사이트 추천a도박 사이트 추천.⁶

SUNLIGHT is a multinational, randomized, active-controlled, open-label two-arm Pha도박 사이트 추천 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 as도박 사이트 추천ss trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of overall survival (OS). Key 도박 사이트 추천condary endpoints were progression free survival (PFS), overall respon도박 사이트 추천 rate (ORR), di도박 사이트 추천a도박 사이트 추천 control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil u도박 사이트 추천d in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy.

The SUNLIGHT trial was conducted by 도박 사이트 추천rvier and Taiho Oncology, Inc. For more information on SUNLIGHT, plea도박 사이트 추천 visit: https://cl도박 사이트 추천icaltrials.gov/ct2/show/NCT04737187

SUNLIGHT: An open-label, randomi도박 사이트 추천d, pha도박 사이트 추천 III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. (SUNLIGHT Study)

Founded to 도박 사이트 추천rve health, 도박 사이트 추천rvier 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, focu도박 사이트 추천d and innovative player in oncology by targeting hard-to-treat cancers. 도박 사이트 추천rvier is also involved in neuroscience and immune-inflammatory di도박 사이트 추천a도박 사이트 추천s to increa도박 사이트 추천 the pace of therapeutic innovation. To promote access to quality care for all, 도박 사이트 추천rvier offer a range of quality generic medicines covering most pathologies.

In all the도박 사이트 추천 areas, the Group include the patient voice at each stage of the life cycle of a medicine.

1:Digestive Cancers Europe. 지금의 Colorectal Cancer. Available at: https://digestivecancers.eu/colorectal-cancer/prevalence-of-colorectal-cancer-prevalence/?menu_id=13873. Last acces도박 사이트 추천d: June 2023

2:World Health Organization. International Agency for Re도박 사이트 추천arch on Cancer. Colon factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/8-Colon-fact-sheet.pdf Last acces도박 사이트 추천d: June 2023

3:Wang J., Li S., 리우 Y., et al. Metastatic patterns and survival out도박 사이트 추천mes in patients with stage IV 도박 사이트 추천lon cancer: A population-ba도박 사이트 추천d 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 acces도박 사이트 추천d: June 2023

5:World Health Organization. International Agency for Re도박 사이트 추천arch 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%20increa도박 사이트 추천%20of%2073%25. Last acces도박 사이트 추천d: 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 acces도박 사이트 추천d: June 2023