2015年9月22日美国食品和药品监管局(FDA)批准Lonsurf(两药组合药丸，曲氟尿苷和tipiracil)对有晚期结肠直肠癌形式对其他治疗不再反应患者。.
FDA的药品评价和研究中心血液学和肿瘤产品室主任 Richard Pazdur，M.D说：“过去十年围绕结肠直肠癌，在如何能检测和治疗这个常常破坏性疾病带来了新的认识，” “但有许多患者仍需要另外选择，而今天的批准证明了FDA与企业合作，开发新的药物仍然存在未满足的需求疾病领域的承诺。”
按照美国国立癌症研究所结肠直肠癌在美国男性和妇女中第三位最常见非-皮肤癌，同时仍是美国癌相关死亡第二大原因，过去十年结肠直肠癌病例数和相关食物已下降，部分归功于筛选，例如结肠镜检查。
Lonsurf是一个口服药物意向治疗有晚期(转移)结肠直肠癌患者以前曾被化疗和生物学治疗治疗过。
在一项国际，随机化，双盲研究涉及800例with 以前治疗过转移结肠直肠癌患者中评价Lonsurf的疗效和安全性。
研究参加者接受Lonsurf加最佳支持疗法，或安慰剂加最佳支持疗法直至他们的疾病恶化或副作用变成不能耐受。研究的主要终点是总体生存和次要终点是无进展生存。用Lonsurf治疗患者平均生存7.1个月与之比较用安慰剂治疗患者为5.3个月。对用Lonsurf患者平均至疾病进展时间为2月，与之比较接受安慰剂患者为1.7个月。
用Lonsurf治疗最常见副作用是贫血，与感染斗争白血细胞减低(中性粒细胞减少)或血小板减少，体质虚弱，极度疲劳和缺乏能量(疲乏)，恶心，食欲减退，腹泻，呕吐，腹痛和发热。
FDA建议卫生保健提供者在Lonsurf每个疗程开始前得到完整血细胞计数和监视患者治疗始终，因为Lonsurf可能致血细胞和血小板生成严重减低(骨髓抑制)。、
还鼓励卫生保健提供者忠告妇女当服用 Lonsurf时对发育胎儿潜在风险。服用Lonsurf妇女不应哺乳喂养。
Lonsurf由在新泽西州普林斯顿Taiho Oncology公司制造。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm
New Drugs Online Report for trifluridine + tipiracil
Information
Generic Name: trifluridine + tipiracil  
Trade Name: Lonsurf 
Synonym: TAS102; T15/T20 
Entry Type: New molecular entity  
Development and Regulatory status
UK: Pre-registration (Filed) 
EU: Pre-registration (Filed) 
US: Pre-registration (Filed) 
UK launch Plans: Available only to registered users
Actual UK launch date: 
Comments
Mar 15: Taiho submits a marketing authorisation application to the EMA for use of tipiracil/trifluridine in the treatment of refractory metastatic CRC. The submission is supported by results from the PIII RECOURSE trial [2].
18/03/2015 16:58:30
Oct 14: Taiho initiates a rolling NDA submission to the US FDA for tipiracil + trifluridine for treatment of refractory, metastatic colorectal cancer. The NDA is supported by the results of the PIII RECOURSE trial. The company has received Fast Track designation for the product in this indication [1].
21/11/2014 16:19:54
Trial or other data
Jun 14: Efficacy and safety data from the RECOURSE trial presented at the 39th European Society for Medical Oncology Congress (ESMO-2014). The trial met its primary endpoint of demonstrating an improvement in overall survival in patients treated with tipiracil + trifluridine vs. placebo [1].
21/11/2014 16:26:06
Jun 12: Taiho initiates the PIII RECOURSE trial of tipiracil + trifluridine plus best supportive care (BSC) versus placebo plus BSC in patients with advanced, metastatic, refractory, unresectable colorectal cancer (TPU-TAS-102-301; NCT01607957). Tipiracil + trifluridine will be dosed at 35mg/m2 twice-daily on days 1-5 and 8-12 of each 28-day cycle. Approx 800 patients will be enrolled in the US, Australia, the UK, Austria, Belgium, France, Czech Republic, Germany, Ireland, Italy, Sweden, Spain and Japan [1].
21/11/2014 16:21:26
References 
Available only to registered users
 Category
BNF Category: Cytotoxic drugs (08.01)
Pharmacology: A combination of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic thymidine based nucleoside analogue which is incorporated into deoxyribonucleic acid (DNA) in tumour cells following phosphorylation. 
Epidemiology: In 2011, 34,044 newly diagnosed cases of colorectal cancer were registered in England (18,971 men and 15,073 women). In 2012, there were 13,236 deaths from bowel cancer in England—7,200 men and 6,036 women. At the time of diagnosis, an estimated 20-50% of CRC patients have metastatic disease. Also, of the people who have undergone early stage surgery for CRC, about 50-60% will go on to develop metastatic disease, most commonly in the liver. 
Indication: Colorectal cancer
Additional Details: metastatic in adults previously treated with, or are not considered suitable for fluoropyrimidine-based chemotherapy, anti-VEGF therapy, and/or anti-EGFR therapy
Method(s) of Administration 
Oral
Company Information
Name: Taiho
US Name: Not Known
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Awaiting Update
Implications Available only to registered users