News! Domestic innovative drug epinemine, the United States FDA fast-track qualification.

Colorectal cancer is one of the most common malignant tumors. The incidence rate and mortality rate of colorectal cancer in China are fifth. Nearly half of the patients are diagnosed with advanced stage or recurrence after operation.chemotherapy is the main method for patients with advanced colorectal cancer. Although it can effectively alleviate the disease, it has great side effects and is prone to drug resistance, so it is difficult to guarantee the survival time and quality of life.however, the posterior line therapy is very limited and the treatment is in a dilemma.furquitinib is used to treat patients with metastatic colon cancer (mCRC), which provides a new choice for the treatment of colorectal cancer.the US Food and Drug Administration (FDA) has granted its core target drug fast track qualification.moreover, on November 28, 2019, the national health insurance bureau announced that furquitinib was officially included in the medical insurance list.01 furoquitinib is a new, oral and highly selective vascular endothelial growth factor receptor (VEGFR) targeting drug. It inhibits the formation of tumor neovascularization by inhibiting the phosphorylation and downstream signal of VEGFR on the surface of vascular endothelial cells, thus inhibiting tumor growth and metastasis.the advent of furquitinib has changed the plight of patients with advanced colorectal cancer, which has brought new hope for targeted therapy.as an innovative class 1 new drug in China, furquitinib has attracted the attention of the industry and patient groups from R & D to approval and marketing, and has become the recommendation of targeted anti vascular therapy for advanced colorectal cancer.02 clinical trial to test the efficacy and safety of furquitinib, authoritative studies were conducted on 416 patients with advanced metastatic colorectal cancer who had received at least second-line standard chemotherapy and were still in progress.the patients were randomly divided into two groups according to the ratio of 2:1: furquitinib group (278 patients): oral furquitinib, 5 mg each time, once a day, three weeks after the drug withdrawal for a week, combined with the best support treatment.placebo group (138 patients): placebo combined with best supportive treatment.results: (1) significantly prolonged overall survival: the median overall survival (MOS) of the furquitinib group was 9.3 months, which was 2.7 months longer than that of the placebo group, significantly reducing the risk of death by 35%.(2) significantly prolonged median progression free survival: compared with 1.8 months in the placebo group, the median progression free survival (MPFs) in the furquitinib group was extended to 3.7 months, and the risk of disease progression was reduced by 74%.(3) excellent disease control rate: the disease control rate of the furquitinib group was as high as 62.2%, and the median disease stable time was as long as 5.5 months.(4) good tolerance: at the recommended dose, the overall tolerance of furquitinib group was good, and no new or unexpected serious safety problems occurred.further subgroup test analysis was performed. (1) the curative effect of liver metastasis subgroup was significant. compared with the control group, the overall survival time of the furquitinib group was prolonged, and the risk of death was reduced by 41%. Nearly 70% of the patients used furquitinib to achieve tumor control. (2) previous use of targeted drugs did not affect the efficacy. studies have shown that, regardless of whether the patients have previously used bevacizumab or cetuximab targeted drugs, the KRAS gene mutation status is, and the survival time of the latter line of furquetinib treatment is longer than that of the control group. in 2018, the full text of fresco research results was published in international authoritative journal "JAMA Oncology". 03 based on its excellent efficacy and good tolerability, it was approved by the State Drug Administration on September 5, 2018, and was approved for marketing within 12 months for the treatment of metastatic colorectal cancer patients who had received fluorouracil, oxaliplatin and irinotecan before becoming a national class I new drug. according to the highest level of class 1A evidence and the strongest level I recommendation, the standard scheme of third line treatment is recommended. at the same time, due to its significant efficacy and safety for patients with advanced colorectal cancer complicated with liver metastasis, furquetinib capsule has also been included in the "2018 edition of Chinese guidelines for the diagnosis and comprehensive treatment of colorectal cancer with liver metastasis", which confirms the undoubted strength of furquetinib. on November 28, 2019, the national health insurance bureau announced that furquitinib was officially included in the medical insurance list. the basic payment price of a single 1mg medical insurance is 94.5 yuan, and the standard price of a single 5mg medical insurance is 378 yuan. It is estimated that patients will pay about 2000-3000 yuan per month at their own expense. The fee reduction will be officially implemented from January 1, 2020. the medication pressure of patients with colorectal cancer was significantly reduced, and the dilemma of "difficult medication and expensive medical treatment" was solved. The U.S. Food and Drug Administration (FDA) granted the fast track qualification of furquitinib. On the one hand, it shows the urgency of the global clinical needs for the treatment of advanced colorectal cancer, and on the other hand, it also reflects the recognition of the safety and effectiveness of the past clinical data of furquitinib 。 this fast track qualification has accelerated the progress of clinical trials and marketing registration of furquitinib in the United States and even the world, providing more safe and effective treatment options for more patients with advanced metastatic colorectal cancer. at the same time, the R & D and marketing of furoquitinib also demonstrated the improvement of China's scientific and technological innovation ability, which is an important sign that the national new drug innovation and development are in line with the world and mature. it is believed that there will be more independent research and development of anti-cancer drugs in the future, which will bring more new choices to the patients. scan code consultation gene testing clinical recruitment service