英文药名：KYPROLIS（carfilzomib for Injection）
Ono "Kaipurorisu intravenous drip infusion for the 10mg, 40mg" get the domestic manufacturing and marketing approval of
Proteasome inhibitor "Kaipurorisu (R) for Intravenous Infusion 10mg, 40mg"
Domestic manufacturing and marketing approval for relapsed or refractory multiple myeloma
Ono Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Osaka, President: Akatsuki Sagara, hereinafter referred to as "Company"), a proteasome inhibitor "Kaipurorisu (R) for Intravenous Infusion 10mg, 40mg" (generic name: carfilzomib, below , for the "Kaipurorisu"), today, that it has acquired the domestic manufacturing and marketing approval for the treatment of relapsed or refractory multiple myeloma, will be announced.
Multiple myeloma is a blood cancer that is caused by the abnormal plasma cells in the bone marrow, the total number of patients in Japan has been about 18,000 people and reported (※). Currently, treatment for multiple myeloma There are multiple, repeatedly traveling through the remission and relapse, or any treatment method is also not uncommon even if you want to migrate to the pathology of effective and not become intractable. In addition, in the long-term treatment has been reported side effects or complications, you might want to Difficult to treatment. From these things, it has the development of new therapeutic agents is expected for multiple myeloma.
Kaipurorisu, the Company was introduced in September 2010 than the United States Onyx Pharmaceuticals Inc (now Amgen Inc. subsidiary), is a proteasome inhibitor with high selectivity. Proteasome enzyme complex present in a cell, it has the effect of decomposing poly-ubiquitinated proteins, cell proliferation, and control the differentiation and functional cell death. Kaipurorisu by inhibiting the proteasome, induces a functional cell death of myeloma cells.
Kaipurorisu is, in July 2012 in the United States, bortezomib and have a previous history of treatment at least twice, including the immunomodulatory agent, multiple myeloma showed disease progression within 60 days, during or after the treatment the last treatment period quickly approved as a single agent therapy and efficacy and effects, and for combination therapy with lenalidomide and dexamethasone in July 2015, the approval of the multiple myeloma with the previous treatment history of one to three times as the efficacy and effect we acquired additional. In addition, in monotherapy in January 2016, it has obtained the full approval multiple myeloma with the previous treatment history of one or more times as the efficacy and effect. In Europe, in combination therapy with lenalidomide and dexamethasone in November 2015, it has been approved multiple myeloma with a previous history of treatment at least once as the efficacy and effect
It should be noted that, in Japan, on August 20, 2015, the Ministry of Health, Labour and Welfare, has been designated as orphan drug as efficacy and effect, which is scheduled for "relapsed or refractory multiple myeloma."
The Company, Kaipurorisu proper and effective in the more clinical data to be used accumulated we believe it is important. In accordance with the conditions of approval of this drug, conducted use results survey of post-marketing approval (full example research), to collect clinical data on the safety and efficacy, we will take necessary measures in the proper use of this drug .