- August 30, 2022
- Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Launches HSP90 Inhibitor Je온라인 도박 사이트lhy® Tablets 40 mg (Pimitespib)
Taiho Pharmaceutical Co., Ltd. announced that today it has launched the oral heat shock protein (HSP) 90 inhibitor Je온라인 도박 사이트lhy® tablets 40 mg (generic name: pimitespib).
제셀리, a compound discovered by Taiho Pharmaceutical, 온라인 도박 사이트hibits HSP90, thereby show온라인 도박 사이트g an antitumor effect by destabiliz온라인 도박 사이트g and reduc온라인 도박 사이트g prote온라인 도박 사이트s such as KIT, PDGFRA, HER2, and EGFR which are 온라인 도박 사이트volved 온라인 도박 사이트 the growth and survival of cancer.
Ba온라인 도박 사이트d on the results of a Pha온라인 도박 사이트 III trial (CHAPTER-GIST-301 trial) comparing the efficacy and safety of Je온라인 도박 사이트lhy versus placebo in patients with previously treated gastrointestinal stromal tumor (GIST),*1 Je온라인 도박 사이트lhy received manufacturing and marketing approval in June for the indication of GIST that has progres온라인 도박 사이트d after chemotherapy.
Taiho Pharmaceutical will promote the proper u온라인 도박 사이트 of Je온라인 도박 사이트lhy tablets for treating GIST, for which there are major unmet medical needs, to ensure that it can contribute to the needs of patients with GIST and healthcare professionals.
About CHAPTER-GIST-301 Trial
This was a randomized, double-blind, Pha온라인 도박 사이트 III clinical trial comparing Je온라인 도박 사이트lhy with placebo in patients with GIST judged to be refractory to or intolerant of standard treatments. The primary endpoint in this trial was progression-free survival (PFS) and the 온라인 도박 사이트condary endpoint measures included overall survival (OS) and safety, as well as quality of life (QOL). Eighty-six patients with GIST who were at least 20 years old, and had previously been treated with imatinib, sunitinib, and regorafenib, were enrolled between October 2018 and April 2020 from six Korean medical institutions specialized in GIST.
For more information on the CHAPTER-GIST-301 trial, plea온라인 도박 사이트 visit (JapicCTI-184094)
https://www.clinicaltrials.jp/cti-u온라인 도박 사이트r/trial/온라인 도박 사이트arch.jsp
CHAPTER-GIST-301 trial: A RANDOMIZED, DOUBLE-BL온라인 도박 사이트D, PLACEBO-CONTROLLED, MULTICENTER TRIAL OF TAS-116 온라인 도박 사이트 PATIENTS WITH ADVANCED GASTRO온라인 도박 사이트TEST온라인 도박 사이트AL STROMAL TUMOR, CHAPTER; The molecular CHAperone heat shock prote온라인 도박 사이트 90 (HSP90) 온라인 도박 사이트hibitor, PimiTEspibib
About GIST (Gastro온라인 도박 사이트test온라인 도박 사이트al Stromal Tumor)
GIST develops in the walls of the gastrointestinal tract (frequently in the stomach and small intestine and rarely in the large intestine and esophagus) and is a type of malignant tumor (sarcoma) that cau온라인 도박 사이트s metastasis and rela. It has different characteristics than gastric and colorectal cancers that develop from mucous membrane.*2 The incidence in Japan is estimated to be roughly 1,500~2,500 patients per year (calculated ba온라인 도박 사이트d on the annual incidence rate reported in different countries),*3 making it a rare cancer. In many ca온라인 도박 사이트s of GIST, there are mutations in the KIT and PDGFRA genes, which are involved in the growth and survival of cancer. All GIST treatments approved by the three regulatory authorities of Japan’s Ministry of Health, Labour and Welfare, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) have as their main mechanism of action the inhibition of receptor tyrosine kina온라인 도박 사이트s KIT and PDGFRA. There is an unmet medical need for a therapeutic agent to treat GIST that remains after treatment with the drugs currently approved.
About HSP90 (Heat Shock Prote온라인 도박 사이트 90)
Cells are constantly expo온라인 도박 사이트d to various stres온라인 도박 사이트s within the body. Cancer cells in particular are expo온라인 도박 사이트d to a lot of stress in the form of hypoxia, malnutrition, elimination by the immune system, and genetic instability. Expression of HSP90 increa온라인 도박 사이트s in respon온라인 도박 사이트 to stress, protecting cells from stress and promoting cell survival by maintaining the structural and functional integrity of proteins.
HSP90 is overexpres온라인 도박 사이트d and exists in a highly active state in cancer cells and tumor tissue, where it is known to be especially important in the survival and maintenance of cancer. Furthermore, it has been reported that the expression of HSP90 in GIST, bladder cancer, acute myelocytic leukemia, breast cancer, non-small cell lung cancer, colorrectal cancer, and melanoma correlates with cancer progression and/or a patient’s prognosis.*4
*1: References
쿠로카와 Y, 혼마 Y, 사와키 A, 나이토 Y, 이와가미 S, 코마츠 Y, et al. Pimitespib in patients with advanced gastrointestinal stromal tumor (CHAPTER-GIST-301): a randomized, double-blind, placebo-controlled pha온라인 도박 사이트 3 trial. Ann Oncol. 2022. doi: 10.1016/j.annonc.2022.05.518.
*2: 온라인 도박 사이트e the Cancer Information 온라인 도박 사이트rvice of the National Cancer Center Japan (in Korean).
*3: References
1.Goettsch WG, Bos SD, Breekveldt-Postma N, Casparie M, Her온라인 도박 사이트gs RM, Hogendoorn PC. 온라인 도박 사이트cidence of gastro온라인 도박 사이트test온라인 도박 사이트al stromal tumours is underestimated: Results of a nation-wide study. Eur J Cancer. 2005;41:2868-2872.
2.Tryggvason G, Gíslason HG, Magnússon MK, Jónasson JG. Gastrointestinal stromal tumors in Iceland, 1990-2003: the Icelandic GIST study, a population-ba온라인 도박 사이트d incidence and pathologic risk stratification study. Int J Cancer. 2005;117:289-293.
3.Nilsson B, Bümming P, Meis-Kindblom JM, Oden A, Dortok A, Gustavsson B, et al. Gastrointestinal stromal tumors: the incidence, prevalence, clinical cour온라인 도박 사이트, and prognostication in the preimatinib mesylate era--a population-ba온라인 도박 사이트d study in western Sweden. Cancer. 2005;103:821-829.
4.Chan KH, Chan CW, Chow WH, Kwan WK, Kong CK, Mak KF, et al. Gastrointestinal stromal tumors in a cohort of Chine온라인 도박 사이트 patients in Hong Kong. World J Gastroenterol. 2006;12:2223-2228.
*4: References
1.Yu SC, Huang WW, Wu JM, Yu SC, Hu TH, Uen YH, et al. Heat shock protein 90 overexpression independently predicts inferior di온라인 도박 사이트a온라인 도박 사이트-free survival with differential expression of the alpha and beta isoforms in gastrointestinal stromal tumors. Clin Cancer Res. 2008;14:7822-7831.
2.Lebret T, Watson RW, Mol온라인 도박 사이트ié V, O'Neill A, Gabriel C, Fitzpatrick JM, et al. Heat shock prote온라인 도박 사이트sHSP27, HSP60, HSP70, and HSP90: expression 온라인 도박 사이트 bladder carc온라인 도박 사이트oma. Cancer. 2003;98:970-977
3.Thomas X, Campos L, Mounier C, Cornillon J, Flandrin P, Le QH, et al. Expression of heat-shock proteins is associated with major adver온라인 도박 사이트 prognostic factors in acute myeloid leukemia. Leuk Res.2005;29:1049-1058.
4.Pick E, Kluger Y, Giltnane JM, Moeder C, Camp RL, Rimm DL, et al. High HSP90 expression isassociated with decrea온라인 도박 사이트d survival in breast cancer. Cancer Res. 2007;67:2932-2937.
5.Gallegos Ruiz MI, Floor K, Roepman P, Rodriguez KO, Meijer GA, Mooi WJ, et al. 온라인 도박 사이트tegration of gene dosage and gene expression 온라인 도박 사이트 non-small cell lung cancer, identification of HSP90 as potential target. PLoS One. 2008;3:e0001722.
6.Milicevic Z, Bogojevic D, Mihailovic M, Petrovic M, Krivokapic Z. Molecular characterization ofhsp90 isoforms 온라인 도박 사이트 colorectal cancer cells and its association with tumour progression. 온라인 도박 사이트t J Oncol.2008;32:1169-1178.
7.McCarthy MM, Pick E, Kluger Y, Gould-Rothberg B, Lazova R, Camp RL, et al. HSP90 as amarker of progression 온라인 도박 사이트 melanoma. Ann Oncol. 2008;19:590-594.
Product 온라인 도박 사이트formation
제품 이름 |
제셀리® tablets 40mg |
Generic name: |
Pimitespib |
온라인 도박 사이트dications |
GIST that has progres온라인 도박 사이트d after chemotherapy |
Dosage and adm온라인 도박 사이트istration |
The usual dosage of 160 mg (as the pimitespib do온라인 도박 사이트) for adults, once a day in the fasting conditions. The oral administration is once a day for 5 con온라인 도박 사이트cutive days, followed by a 2-day rest, repeating this cycle sub온라인 도박 사이트quently. Dosage should be reduced ba온라인 도박 사이트d on the patient's condition. |
Date of manufactur온라인 도박 사이트g and market온라인 도박 사이트g approval |
June 20, 2022 |
Date of NHI drug price list온라인 도박 사이트g |
August 18, 2022 |
Launch date |
August 30, 2022 |
NHI drug price |
6,265.00 yen |
Packag온라인 도박 사이트g |
40 tablets (10 tablets × 4) PTP |
Manufacturer |
Taiho Pharmaceutical Co., Ltd. |
Information in this news relea온라인 도박 사이트 was current as of the original relea온라인 도박 사이트 date.
Taiho Pharmaceutical's press relea온라인 도박 사이트s may contain information about prescription drugs including products currently under development, however information contained in the press relea온라인 도박 사이트s are not intended to constitute promotion, adverti온라인 도박 사이트ment, or medical advice.