FDA approves Taiho Oncology's Lonsurf for treatment of adult patients with stomach cancer

recentlyhttp://
, Taiho Oncology, a u.Ssub-http://
companytaiho, announced that the U.SFood andDrug(http://Administration (
FDA(http://, had approved Lon (trisurffrancie/tipiracil, TAS-102) for the use of at least two chemotherapy regimens, including or eucalyptus or Ilitocon; if applicable, HER2/neu targeted therapy) for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinomathis approval, expanding Lonsurf's insetness in the United States, which has previously been approved for metastatic colorectal cancer (mCRC) patients who have undergone standard chemotherapyLonsurfLonsurf is a new oral anti-metabolic compound drug 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 cells synthesis (http:// , TPI can inhibit the risk of FTD decomposition-related thymosin phosphatase, reduce the degradation of FTD, maintain the concentration of FTD blood medicine 　　The FDA approved Lonsurf through a priority review program based on data from a global, randomized Phase III clinical study The study, conducted in patients with advanced treatment of stomach cancer or gastroesophageal adenocarcinoma that had previously been treated with standard therapy or was intolerant of standard therapy, assessed the efficacy and safety of the Lonsurf Combined Best Support Therapy (BSC) program relative to the placebo-combined BSC regimen results showed that the study reached the primary and secondary endpoints: in the overall study group, the Lonsurf-BSC program achieved a 31% improvement in total survival and statistical significance compared to the placebo-BSC programme, reduced the risk of death by 31% (HR-0.69, single-arm p.00029), and the median OS by 2.1 months (5.7 months vs 3.6) The full results of the TAGS study were presented at the european Society (ESMO) Conference (http:// and published in The Lancet Oncology 　　On January 17 this year, Dapeng Pharmaceutical (http:// released data on the efficacy and safety of subgroups of gastric excision patients in the TAGS study at the 2019 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO-GI) These results are consistent with those of the overall research community In the TAGS study, 221 (44%) of the 507 randomized mGC patients had undergone gastric excision (147 lonsurf treatment and 74 placebo treatment), reflecting the real-world patient population diagnosed with mGC The results showed that Lonsurf had an extended total survival period compared to placebo in this patient subgroup, which was not related to previous gastric excision as of February 2019, Lonsurf has been approved by 66 countries worldwide for treatment of patients with advanced metastatic colorectal cancer (mCRC) for mCRC adult patients who have previously received or are not suitable for existing treatments(including fluorouriator, oxalyplatinum pyl or Ilitocon-based chemotherapy, anti-VEGF preparations, anti-EGFR preparations)