CHMP recommends approval of Lonsurf for treatment of adult patients with metastatic stomach cancer

Recently, French drugmaker Servier and partner Tai
ho Pharmaceutical http://announced that the EuropeanMedicines(http://Authority (
http://Products(http://Committee for human medicine
sinology (http:// has recommended the approval of Lonuridsurf (http:// for the treatment of at least 2 systems to control the treatment of advanced cancer patients with advanced stage sedativesIn the U.Sregulatory sector, Lonsurf received approval from theFDA(http://at the end of February for the treatment of adult patients who have previously received at least two chemotherapy regimens (including fluoroquine, platinum, or yewe or ilicocon; her2/neu targeted therapy, if applicable), for adult patients with gastrointestinal or gastroesophageal esophageal coesophageal cancerThe approval expands Lonsurf's u.Sindications, a drug previously approved for metastatic colorectal cancer (mCRC) patients who have undergone standard chemotherapyAbout Lonsurf
Lonsurf is a new oral anti-metabolic compounddrug(http://consisting of the anti-tumor nucleoside analogue FTD (trifluridine) and thoracic phosphatine inhibitor TPI (tipiracil)Among them, FTD can replace thymus in the DNA replication process directly into the DNA double-stranded, leading to DNA dysfunction, interference with the DNA of cancer cellssynthesis(http://, TPI can inhibit the risk of FTD decomposition-related thymosin phosphatase, reduce the degradation of FTD, maintain the concentration of FTD blood medicineAbout TAGS
Lonsurf's Listing Permit Application (MAA) in the European Union is based on data from a global Phase III clinical study tags (TAS-102 Gastric Study)This is a randomized, double-blind study conducted in patients with metastatic gastric cancer that is difficult to treat with standard therapy, and the efficacy and safety of the Lonsurf Joint Best Support Therapy (BSC) program compared to the placebo-combined BSC protocol was evaluated 　　The results showed that the study reached the primary and secondary endpoints: in the overall study group, the Lonsurf-BSC programme achieved a 31 % improvement in total survival and statistical significance (OS) compared to the placebo-BSC programme, and a 31% reduction in the risk of death (HR-0.69.95) %CI: 0.56-0.85, p.00029), median OS extended by 2.1 months (5.7 months vs 3.6 months), the overall safety is consistent with the safety of Lonsurf treatment mCRC, mainly reported hematological adverse events 　　As of July 2019, Lonsurf has been approved by 68 countries worldwide for treatment of patients with advanced metastatic colorectal cancer (mCRC) for mCRC patients who have previously received or are not suitable for existing treatments(including fluorouriatorine, othaliquinol or Ilitocon-based chemotherapy, anti-VEGF preparations, anti-EGFR preparations) for patients with advanced metastatic colorectal cancer (mCRC) 　　In February 2019, Lonsurf approved new indications in the United States for the treatment of adult patients with metastatic gastric cancer (mGC)/metastatic esophageal junction adenocarcinoma (mGEJC)