European Commission approves Lonsurf for treatment of adult patients with metastatic stomach cancer

recently, French drugmaker Sviar and partner DapengPharmaceutical(http://announced that the European Commission (EC) has approved Lonsurf (trifluridine/tipiracil) for the treatment of adult patients who have previously received at least two systematic treatment options to control metastatic gastric cancer of advanced diseaseLonsurfLonsurf is a new oral anti-metabolic compounddrug(http://consisting of the anti-tumor nucleoside analogue FTD (trifluridine) and thoracic phosphatine inhibitor TPI (tipiracil)In the European Union, Lonsurf is approved as a single therapy for the treatment of adult patients who have previously received currently available therapies (including fluoride-containing, ochalyplatin, chemotherapy regimen-containing, anti-VEGF preparations, anti-EGFR preparations) or those not suitable for these treatments for metastatic colorectal cancer (mCRC)In the United States, 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 yew or iliquinone; HER2/neu targeted therapy, if applicable)The approval expands Lonsurf's indications in the United States, where the drug has previously been approved for metastatic colorectal cancer (mCRC) patients who have undergone standard chemotherapyThe EU approval is based on data from a global Phase III clinical study of 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 evaluated the efficacy and safety of the Lonsurf Joint Best Support Therapy (BSC) protocol relative to the placebo-combined BSC protocol 　　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 compared to the placebo-BSC programme, and reduced the risk of death by 31% (HR-0.69.65%:CI:CI:0.56-0.85), p.00029, and median OS 2.1 months (5.6 months vs vs vs. 　　In terms of safety
overall safety is consistent with the safety of Lonsurf treatment mCRC, which mainly reports hematological adverse events