Verofinil, a new Roche melanoma drug, was approved in China

  On March 22, Shanghai Roche Pharmaceutical Co., Ltd announced that according to the technical review results of the drug review center of the State Food and drug administration, another new drug targeted by Roche Group, zobofu ® (vemurafenib), was approved for the treatment of brafv600 mutation positive non resectable or metastatic melanoma determined by CFDA approved test methods Zobov ® is the first high selective BRAF inhibitor approved on the market in China, which can significantly reduce the risk of death and tumor progression in patients with advanced malignant melanoma Zobov ® suppresses and destroys cancer cells through more precise personalized treatment and selective and powerful combination with cancer causing BRAF kinase, which stops the growth and even death of cancer cells Melanoma is a kind of malignant tumor derived from melanocytes, and it is the most malignant tumor in skin tumors, which is prone to distant metastasis About 26% of Chinese melanoma patients have BRAF gene mutations The most common mutations in BRAFV600E (about 80% of all mutations) and brafv600k (5-30% of all mutations) With the growth of melanoma, cancer cells penetrate deeper into the skin and mucous membrane, eventually to the blood vessels or lymphatic channels, and quickly spread to the whole body and major organs Patients with unresectable or metastatic melanoma usually have short survival, poor prognosis and worse prognosis with BRAF mutation Guo Jun, a professor at Peking University Cancer Hospital, said that before zobofu ® went on the market, there were basically no effective treatment drugs for melanoma patients with BRAF mutation after metastasis Traditional treatment methods mainly depended on chemotherapy, but the effective rate of chemotherapy for these patients was less than 7%, and the progression free survival was only about 1.4 months "In the past, we really had no choice, but this time zobov ® was approved by the State Food and drug administration, which is of far-reaching significance and great significance This means that for decades, we finally have a second new drug for the treatment of metastatic melanoma in addition to dacarbazine, and the efficiency is 7-8 times higher than that of dacarbazine! As the leader of this research in China, I feel honored and gratified that our country's BRAF mutant melanoma patients finally have effective treatment drugs! Although it's five years later than that of foreign countries, after all, I'm really happy and excited that we finally have the first effective weapon to treat melanoma I believe that in the near future, we will have more and more effective weapons, so that the melanoma patients in our country can get better treatment and long-term survival! " Figure: Professor Guo Jun, Peking University Cancer Hospital, the world's first phase 3 clinical trial (brim-3 test) on the application of BRAF inhibitors in BRAF mutant metastatic melanoma, obtained positive results and was published in the New England Journal of medicine in 2011 Long term follow-up showed that the median overall survival time (OS) and median progression free survival time (PFS) were 13.6 months and 6.9 months, respectively, in patients with melanoma with brafv600 mutation, compared with 1.6 months in patients with dacarbazine, 57% in patients with objective response rate (ORR) and 9% in patients with chemotherapy In addition, zobofu ® as an oral targeted drug, less drug discontinuation due to adverse reactions Ms Zhou Hong, general manager of Shanghai Roche Pharmaceutical Co., Ltd., said: "the approval of zobofu in China will open a new chapter in the treatment of domestic melanoma and bring new hope to Chinese melanoma patients We are particularly grateful to the State Food and Drug Administration and other relevant departments for their unremitting efforts to accelerate the introduction of innovative drugs into China, as well as the experts' selfless support for zobov's accelerated approval In the future, Roche will continue to make efforts in the field of melanoma We look forward to working closely with the State Food and Drug Administration and other departments to make more innovative drugs enter the Chinese market as soon as possible and meet the needs of the vast majority of Chinese patients " Figure: Zhou Hong, general manager of Shanghai Roche Pharmaceutical Co., Ltd at present, zobov ® has been approved in 99 countries and regions including the United States and the European Union, and has been used to treat more than 50000 patients worldwide In addition to zobov ®, there are also MEK inhibitors (cobimetinib) and PDL1 monoclonal antibodies (atezolizumab) in Roche's global innovative drug pipeline for melanoma treatment Different innovative combinations of three drugs are applied to different types of melanoma.