NMPA: Approved Reding Pharmaceutical Oncology Electric Field Therapy for The Market for Glioblastoma Treatment, Ushering in a New Era of Treatment

Today from The Company learned from Reding Pharmaceuticals, the company from Israel, called Optune tumor electric field therapy (TTFields) products to obtain the National Drug Administration (NMPA) innovative medical device qualification, approved today, the first tumor electric field therapy officially ushered inOn September 23 last year, he was qualified for NMPA's innovative medical devicetumor electric field therapy is a tumor treatment that uses specific electric field frequencies to interfere with cell division, inhibit tumor growth and kill cancer cells affected by electric fieldsOptune is the world's first and only U.SFood and Drug Administration (FDA) approved tumor electric field treatment products, has been approved in many countries and regions for the treatment of gliomaOptune tumor electric field therapy for glioblastoma, the efficacy is amazing
has long been a very limited treatment for glioblastoma, mainly surgery-based, combined with radiotherapy and tamoxamine chemotherapy, since the 2005 fda approval of pyrethofa for recurrent glioblastoma patients, no other treatment came outin the international Phase III controlled clinical trial of EF-14, nearly 700 patients with glioma stoicism completed chemotherapy, one group received tamoxifen (chemotherapy) and the other group received a combination of Optune and tamoxifenresults show that, with Optune, there was a significant increase in progress-free survival and total survival (P 0.001)The median progression lifetime increased from 4 months to 6.7 months, while the median lifetime of theincreased from 16 months to 20.9 monthsfive-year survival rate also increased from 5% to 13%studies have also shown that the longer you wear, the betterpatients who spend more than 22 hours a day, the five-year survival rate is close to 30%!this data is encouraging for a disease so challengingAlthough Optune has just been launched in mainland China, tumor electric field treatment was recommended in December 2018 by the National Health and Reform Commission's Regulation synod (2018 edition), which specifically recommends the treatment of new glioblastoma (level 1 evidence) and relapsed high-level glioma (level 2 evidence)tumor electric field therapy to explore more tumors
tumor electric field therapy for four solid tumor indications research has entered the advanced clinical development stage, including non-small cell lung cancer brain metastasis, stomach cancer, pancreatic cancer and ovarian cancerIn the STELLAR study of malignant mesothelioma, Optune combined with chemotherapy, the median total survival reached 18.2 months, while historical data showed that chemotherapy alone was used for only 12.1 monthsrecently released trial data show that for high degree of malignant pleural mesothelioma, tumor electric field therapy, combined with first-line chemotherapy, can extend the survival of patients by 6 months, the total survival of patients treated with combination therapy is 18.2 months, thus becoming the first FDA in 15 years in advanced MPM approved new treatment," according to the information provided by Reding Pharmaceuticals, the patient's one-year survival rate could double when the tumor electric field therapy was used as a first-line treatment for advanced pancreatic cancer, in conjunction with the use of Gisitabin or Gixitambin and gibbelo-combination yew alcohol, according to the data provided byReding Pharmaceuticalsmarket prospects for tumor electric field therapySeptember 2018, and In September 2018, Retin Pharma obtained an exclusive license to promote Optune in Greater China from Novocure, IsraelAnd at the end of 2018, it was quickly launched in Hong Kong, China, for polymorphic glioblastoma, and Hong Kong, China, became the fourth market to list the treatment after the United States, Europe and JapanOptune is a wearable device that looks like a hat made of electric field patches, all of which are connected to a batteryPatients wear no less than 18 hours per dayIn the actual treatment needs to be based on the size of the tumor to design electric field patches, after which the patient's tumor will also change, according to the effect of the treatment adjusted once a month" the product is both a wearable device, and its treatment plan is confirmed by an artificial intelligence software, charging and maintenance technology from Tesla, and also involves big data upload analysis, which can be said to represent the crystallization of black technologyLiang Yi said need to note that although tumor electric field treatment generally does not have systemic toxic side effects, but if wearing electric field patches for several years, may appear skin allergies and other problems Optune alone is similar to chemotherapy Current research data show that the rate of severe adverse reactions in chemotherapy patients is 16%, and the proportion of patients with Optune is 6% what will be the pricing of Optune tumor electric field therapy? Optune's listing in several countries also delivered higher revenue returns for the innovative company Novocure's 2018 financial results show revenue of $248.1 million The number of patients using Optune reached 2,383 in the year (1,637 in the United States, 654 in Germany and Europe/Middle East/Africa and 92 in Japan), an increase of 30% year-on-year Although Optune is recommended in several countries, Optune's treatment is expensive if it is paid only by a single patient A April 2018 study by the American Association for Cancer Research found that in the U.S., treatments without commercial insurance cost $21,000 per person/month, $150,368/person/life year, and $198,032/person/quality-adjusted life year Optune charges monthly treatment fees, so as the treatment lengthens, the overall price increases, and when used in combination with other treatments, the overall cost of treatment will be greater than a single type of treatment However, in terms of its extended survival, or in relation to other innovative drugs, the price is still within reasonable range however, in many countries and regions are pushing for multi-payer treatment for tumor electric fields Since September, tumor field treatment has been covered by Federal Health Insurance In addition, public hospitals in Hong Kong and Macau are actively including it in health insurance reimbursement re-ding is considering whether the future can reduce the cost of the treatment in a way that is produced locally in China to benefit more Chinese patients "Pharmaceutical companies have always said they are doing research and development in science, but they also need to do more research and development in helping patients and improving accessibility, and helping patients find a treatment route through financial innovation, charitable assistance, and creating a patient-centered tumor ecosystem." In addition to the issues of high price connectivity, Ms Leung believes there are still many complex tasks to be done before Optune goes on sale, including pre-doctor training, post-data tracking, product operations, and so on In addition, the patient's daily wearing time of 18 hours in treatment, ensuring patient compliance is also an important proposition in the U.S., the product's back-office support costs are very high and require a 24-hour hotline and maintenance team to provide patient support At present, Reding is also exploring innovative ways of service "Our future patient treatment model is quite complex, so we are already listed in Hong Kong, and the Hong Kong experience will help us do well in the mainland." author: MedSci Source: MedSci Original