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PD-L1 Roche drug approved: How multinationals do cancer immunotherapy
Time:2016-09-14      Class:Industry

Medicine NET, June 24 in China by Wei Zexi incidents resulting in periods of mere mention of immunotherapy, United States treatment breakthrough once again.


Recently, the United States food and Drug Administration (FDA) approved the first drug PD-L1 immunotherapy Tecentriq, used to treat the most common form of bladder cancer, that is locally advanced or metastatic urothelial carcinoma.


According to the FDA said, Tecentriq was the first to be PD-1/PD-L1 inhibitor approved for the treatment of this type of cancer. The approved Roche (Roche) become the Bristol-Myers Squibb (BMS) and Merck (Merck and Co), will be available in the PD-1/PD-L1 field of immunotherapy products the third pharmaceutical company in the world.


"In May, the FDA to Roche for a specific type of cancer immune therapy to speed up approval of advanced bladder cancer. "Roche has said in an interview with the 21st century business Herald," according to the clinical advantages of early evidence, FDA's accelerated approval program ' to the drug has been approved with conditions, filling the unmet clinical needs in critical situations. ”


So far United States approved a total of four immune drugs: Provenge therapeutic vaccine for prostate cancer; Yervoy for the treatment of melanoma, PD-1 drug for melanoma, in Japan, the drug is also used in the treatment of non-small cell lung Squamous Cell Carcinoma, and how the above PD-L1.


And immunotherapy with autologous blood transfusion in China different immunotherapy are approved drugs in developed countries. Roche hopes that similar drugs to speed up entering the Chinese market.


Immunotherapy "parvenu"


Is a malignant tumor of the urinary bladder mucosa of bladder cancer, including bladder and related organs, can be found in the renal pelvis, the ureters and the urethra, is the most common malignant tumor of the urinary system, but also body one of the ten common cancer, Genitourinary cancer incidence in China first.


Urothelial carcinoma is the most common type of bladder cancer, accounting for 90% per cent of the total number of patients with bladder cancer, commonly referred to as bladder cancer refers to the urothelial Carcinoma of the bladder. According to the United States National Cancer Institute (NCI) estimates in 2016, United States 76960 new cases of bladder cancer will be about 16390 people will die from the disease.


Against this disease before treatment is limited and ineffective. The Roche Group's Chief Medical Officer and head of global product development, Dr Sandra Horning said: "Advanced bladder cancer treatment options are very limited. ”


Metastatic urothelial bladder cancer treated in nearly 30 years without significant progress. Tecentriq listing for metastatic urothelial Cancer Group provides an important treatment option.


"Tecentriq provides a targeted PD-L1 for these patients new treatment pathway. "The FDA Center for drug evaluation and research of blood and tumors, MD, Richard Pazdur, Director of the Office," said blocking the PD-1/PD-L1 product is the interaction of the body's immune system and part of the relationship between cancer cell development. ”


Tecentriq PD-1/PD-L1 pathway (human immune cells and a protein found on some cancer cells) as a target. By blocking these interactions, Tecentriq can help the body's immune system to fight cancer cells.


Tecentriq was approved by the FDA in the past two years, with PD-1/PD-L1 as the type of broad targets the latest products in the product. Ventana PD-L1 was also approved (SP142) analysis for determination of protein expression level of tumor-infiltrating immune cells in patients with PD-L1 to help doctors determine which patients might benefit the most from the Tecentriq treatment.


Tecentriq applies to Platinum-containing chemotherapy treatment during or after treatment, the disease progression in patients with, or within 12 months of receiving Platinum-containing chemotherapy patients before surgery (neoadjuvant therapy) or after surgery (adjuvant therapy) can be.


According to the FDA's official information, Tecentriq, San Francisco, California by the Genentech (Roche subsidiary) go on sale. Tecentriq Ventana PD-L1 (SP142), analysis of computer-aided diagnosis reagents by Ventana Medical Systems in Tucson, Arizona for sale.


Precise positioning of tumor cells


The body's immune system are the first line of defense against cancer cells, t-cells to search for substances harmful to the human body, scanning, distinguish between normal and abnormal cells, and attack and destroy abnormal cells.


But many tumors can block t cell activation and escape the immune system of review. And if Tecentriq is a protein binding of monoclonal antibodies, called PD-L1. T-cell activation by inhibiting PD-L1,atezolizumab can make to stimulate the patient's immune system, accurate to identify and destroy tumor cells.


The Roche Group Chief Executive, Dr Schwann (Dr.Severin Schwan) says, "activating the body's own immune system to fight cancer, such ideas from birth to practice after more than 100 years in time. And proved that we could even to cure metastatic cancer. ”


Before the approved Roche, Bristol-Myers Squibb inhibitors of CTLA4 ipilimumab (brand name: Yervoy) and PD-1 inhibitor Nibolumab (brand name: Opdivo) were granted FDA approval in 2011 and July 2014 in Japan market for the treatment of metastatic or unresectable malignant melanoma.


Its effect is very significant in the part of the crowd, and even melanoma tumors disappear too quickly, resulting in the surface of the skin to form a concave surface. "The wounds haven't healed, the tumor disappeared. "Many oncologists.


MSD pembrolizumab (brand name: Keytruda) is a United States first listed PD-1 inhibitor, as a second-line treatment for advanced melanoma.


At present in breast cancer, lymphoma, lung cancer, Sarcoma, renal cell carcinoma, melanoma, colorectal, bladder cancer, blood cancer, prostate cancer and bone marrow cancer research areas are in tumor immunotherapy.


"Including targeted PD-1, PD-L1 and CTLA-4 immune agents such as monoclonal antibodies, as well as the reactivation of t cells, are anticancer drug development put forward in a new direction and have a profound impact on future cancer treatment market, which is why immunotherapy can get that level of attention and demand reasons. "Burning General Advisory and Executive Director Wang Wenhua said these immune drugs appear to large populations of patients with bladder cancer, its commercial value is self-evident.


Bristol-Myers Squibb and Merck drugs are targeting PD-1, and Roche Tecentriq target is the PD-1/PD-L1 signaling pathway in the complementary PD-L1 with proteins.


"Which is widely expressed on the surface of many immune cells and a variety of cancer cells". Wang Wenhua believes that "Roche Tecentriq indication of the crowd even more, after all, the incidence of Melanoma is far lower than the bladder cancer, and indications of future business prospects also depend on whether it can be expanded to other areas of cancer, Bristol-Myers Squibb and Merck is committed to extend the indications from the Melanoma to a higher incidence of breast cancer, lung cancer and other therapeutic areas. ”


Proportion is expected to exceed 40%


According to Global Data research reports that bladder cancer treatment market will be $ 177.1 million growth from 2015 to 2017 more than $ 646.6 million, showed a trend of rapid growth. The next two years, three new drug market will resume largely stalled on bladder cancer treatment markets.


According to the company report Opportunity Analyzer: bladder cancer – opportunity analysis and forecast of 2017 notes, this market growth will take place in six major markets, including the United States, and France, and Germany, and Italy, and Spain and the United Kingdom, market growth will mainly come from 2016 Telesta Therapeutics MCNA, Roche Atezolizumab in 2017 and Bristol-Myers Squibb Opdivoin listed.


GlobalData business analyst responsible for tumor says: "Atezolizumab the end of 2016 will enter the bladder cancer treatment market, which is one of many in the research of immune inhibitors of checkpoint. These drugs in recent years have provoked a great deal of enthusiasm, because it shows the other difficult to treat the cancer effectively, including metastatic melanoma and lung cancer. ”


"With Atezolizumab as the first immune inhibitors of checkpoint into the bladder cancer treatment market, it will have obvious advantages, this also explains why 2017 the drug's sales were forecast to 43.7% in this market. ”


Now that broad market prospects, and drug companies are in a position to spare no effort.


In 2015, the Roche Group sales of 48.1 billion francs, investment in research and development to 9.3 billion francs. "Roche of individualized cancer immunotherapy research and development plans, including more than 20 research candidate projects, 9 of which are being tested in clinical trials. "Roche reported on the 21st century economy," said all studies including the prospective evaluation of biomarkers to determine the appropriate candidate who could be our medicine. These candidates are as monotherapy, extensive research on types of cancer or in combination with other molecules, including bladder cancer, lung cancer, breast cancer and other solid tumors. ”


Already some of the participants in the domestic market. Among them, BGB-A317 new drug application submitted by Baekje Shenzhou has passed FDA reviews; Taizhou solid bio-Pharm limited Declaration "injection of recombinant humanized anti-PD-1 monoclonal antibody" drugs approved by the CFDA in clinical; hengrui medicine (39.880, 0.00, 0%) PD-1 monoclonal antibody was granted in February 2016 clinic; and biological PD-1 of clinical applications were accepted April 2016.


But due to the immune therapy drug is not listed in the domestic, gave birth to the rise of medical tourism, drug purchasing and other related services. Some domestic and foreign medical institutions and companies began to work together to promote medical services for patients to travel abroad for medical treatment.


"Some of this medical institution is a medical strength and level of medical technology, can bring immediate viable treatment options for patients. "Burning General Advisory founding partners Hou Xuchao said.


"However, drug purchasing can often hear from India or Hong Kong purchase drug disputes and controversy, which has extremely high treatment risks and irregularities. "Hou Xuchao said:" a lot of drugs are generic drugs purchasing, producing their own qualifications and clinical efficacy cannot be effectively guaranteed, and ratio of drug use means that may not match Chinese body traits and need to be extra careful. ”


Now Bristol-Myers Squibb's Opdivo in China, lung cancer clinical trials started in early 2016, Merck started Keytruda in June 2016, non-small cell lung cancer clinical trials in China, Hou Xuchao said "If the positive clinical results, and hoped that they would soon enter the Chinese market, and how an effective treatment option for the majority of domestic patients. ”


Roche says it is committed to become the Shanghai Basel and Roche the world's third largest after San Francisco strategic centre and international standards to enhance the whole industry value chain. In terms of drugs "will accelerate innovation and drug listed in China, for the first time to benefit Chinese patients. ”


Source: China chemical network


 
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