Anticancer agent "Treaxin ® for intravenous infusion 100 mg", released in JapanEisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that in Japan, an anti-cancer agent "Treaxin ® for intravenous drip infusion 100 mg" for indications of low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma (Generic name: bendamustine hydrochloride, hereinafter "Treaxin ®") on December 10th.This product will be the first anti-cancer drug in Japan in Japan, and will be fully deployed to the oncology field in Japan following the United StatesSymbio Pharmaceutical Co., Ltd. (Head office: Tokyo, President: Fumi Yoshida, hereinafter, Symbio) got approval for manufacturing and marketing on October 27 this year and was listed on the drug price on December 10. Based on the license agreement in Japan concluded with Symbio, we will sell.Our company's promotion system of cancer area in Japan will arrange specialized academic staff specializing in cancer area in each area and about 1,400 domestic MRs will provide information. Regarding this drug, we will smoothly carry out the specified use record survey (all cases study) which is specified as the approval condition and promote effective, safe and proper use of this drug."Torexin®" is a new type of anticancer drug with an alkylating agent having a nitrogen mustard skeleton and an antimetabolite-like structure. This product has a high response rate and long-term progression-free survival in Japanese clinical trials, and excellent efficacy was confirmed. In particular, a single complete response to recurrent mantle cell lymphoma confirmed a high complete response rate. The main side effects are reported as myelosuppression, nausea, vomiting, infectious diseases, vasculitis, vascular pain, etc. but shows a manageable and well tolerable safety profile. Today, Symbio is conducting Phase II clinical trials for relapse or refractory middle- and high-grade B-cell non-Hodgkin's lymphoma and untreated multiple myeloma with the aim of adaptation addition.It is estimated that the number of non-Hodgkin's lymphomas in Japan is about 12,000 per year, and it is said to be increasing trend in recent years. Among them, patients with low-grade malignancy often repeat recurrence even if initial remission is observed by initial treatment, and it is known that there are very few cases where the life-extension period is long but the case of recovery is complete. In addition, mantle cell lymphoma is a disease type with less frequent onset, it is often found in advanced stages, and standard treatment is not yet established.We regard the oncology field as a top priority area, and following the "Torexin®" product, the first anti-cancer drug in Japan, a new anti-cancer drug that we are applying for in adaptation for breast cancer We will further enhance products in the field of cancer-related diseases in Japan, such as agent "Eribulin" (generic name), and will further contribute to the satisfaction of diverse needs of cancer patients and their families.[An overview of bendamustine hydrochloride and products and product photographs are attached as reference materials]Reference material1. About bendamustine hydrochlorideBendamustine hydrochloride is an anticancer drug synthesized by Jena Pharma AG of the former East Germany and is now being used as a therapeutic agent for non-Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia, etc. in European countries "Ribomustin® "Or" Levact® "under the product name. In the United States, it is marketed under the product name "TREANDA®" as a remedy for chronic lymphocytic leukemia and recurrent B-cell non-Hodgkin's lymphoma.We have exclusive licensing agreement for joint development and sales in Japan in August 2008 with Symbio in relation to this product, exclusive for development and sales targeting two countries in Singapore and Korea in May 2009 We have a license agreement. In Singapore, our Singapore subsidiary, Eisai (Singapore) Pte. Ltd., has been on sale in September 2010 under the product name "Symbenda®" as a treatment for low grade non-Hodgkin's lymphoma and chronic lymphocytic leukemia2. Product overview of "Torexin®"product name:Treaxin for intravenous drip infusion 100 mgcommon name:Bendamustine hydrochlorideIndications/effects:Recurrent or refractory diseaseLow-grade B-cell non-Hodgkin's lymphomaMantle cell lymphomaDosage/administration:Usually, adults receive 120 mg / ㎡ (body surface area) as bendamustine hydrochloride intravenously over 1 hour once a day. Dose is administered for 2 consecutive days, followed by withdrawal for 19 days. Repeat administration with this as one cycle. Incidentally, weight reduction is made according to the condition of the patient.
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