FDA approves quasi-tyrosine kinase inhibitor LENVIMA for first-line treatment of non-recyctoctable hepatocellular carcinoma

liver cancer is the second leading cause of cancer-related death in the world, with statistics in 2012 showing that around 75,000 people die each year and 78,000 new confirmed cases each yearrecently,, Aishi corporation and Mersadong(announced that the U.SFood andPharmaceutical(
FDA(approved tyrosine kinase inhibitor LENVIMA) for non-reprecable first-line treatment of hepatocellular carcinomathis approval is based on the results of the REFLECT (304 study), thistrialcompared to Sorafeni compared to patients with previously untreated non-rectructible hepatocellular carcinoma (HCC), which, by statistical confirmation of non-poor efficacy, demonstrated the therapeutic effect of lonvastinib in total survival (OS) 1, and significantly improved clinically improved in terms of non-progressive survival (PFS) and mitigation objective (ORR) .3related studies
REFLECT showed that lunvatinib had reached its main endpoint, and by comparing the non-performance statistics of sorafenib, the therapeutic effect of lunvatinib in OS was demonstratedThe median OS in patients treated with lonvantinib was 13.6 months and the median OS in patients treated with Sorafenib was 12.3 months (risk ratio (HR): 0.92; 95% confidence interval (CI): 0.79 - 1.06)OSAnalysis (as pre-defined in the statistical analysis plan, 351 events occurred in the Lunvatini group and 350 events occurred in the Sorafeni group) Regarding the secondary end point of efficacy, according to an independent imaging review based on mRECIST standards, renvathanib showed statistically significant efficacy and clinical improvement compared to Sorafenib, median PFS: Lunvatinib 7.3 months compared to Sorafenib 3.6 months (HR) : 0.64;95 % CI: 0.55 - 0.75; p 0.0001) and ORR: Lunvastini 41 % vs Sorafini 12 % (p 0.0001) adverse reactions in the U.S drug specification, the most common adverse reactions observed in patients treated with lunvastinib were hypertension, fatigue, diarrhea, decreased appetite, joint pain/myalgia, weight loss, abdominal pain, hand and foot syndrome, proteinuria, pronunciation disorder, bleeding events, hypothyroidism and nausea the most common severe adverse reactions in patients treated with lunvastinib were hepatic encephalopathy (5%), liver failure (3%), abdominal water (3%) and decreased appetite (2%) The most common adverse reactions observed in patients treated with Sorafenib were hand and foot syndrome, diarrhea, fatigue, high blood pressure, abdominal pain, loss of appetite, rash, weight loss, and joint pain/myalgia The most common severe adverse reactions in patients treated with sorofani were as fast as 2% and abdominal pain (2%)