Abstract：
:This study aimed to analyze the oncology "drug lag" (i.e., the delay in time required for the approval of oncology drugs) in Japan compared with that in the United States of America (US) or the European Union (EU) and to identify the factors associated with this lag. Using publicly available information, we collected data on 42 approvals of 30 oncology drugs in Japan, the US, and the EU that included dates of drug development initiation, submission, review, and approval. Lags in each step of the process were then examined and compared among the three regions. We found that median submission and approval lag times between Japan and the US were 20.0 and 29.9 months, respectively, while those between Japan and the EU were 14.9 and 21.3 months, respectively. The median review periods for Japan, the US, and the EU were 14.3, 6.0, and 13.2 months, respectively, and the median lag in initiation of oncology drug development between Japan and the US/EU was 38.9 months. The proportion of approvals for which Japanese Phase I registration trials started after corresponding approvals in the US were 39% compared with 47% for the EU. Multivariate analysis suggests that delays in the initiation of drug development and the extended length of the regulatory review period in Japan may contribute to the longer oncology drug lag observed in Japan compared with that of the US or EU.
journal_name
Invest New Drugsjournal_title
Investigational new drugsauthors
Yonemori K,Hirakawa A,Ando M,Hirata T,Yunokawa M,Shimizu C,Katsumata N,Tamura K,Fujiwara Ydoi
10.1007/s10637-011-9638-0subject
Has Abstractpub_date
2011-08-01 00:00:00pages
706-12issue
4eissn
0167-6997issn
1573-0646journal_volume
29pub_type
杂志文章abstract：:We have previously described a human pancreatic-ribonuclease variant, named PE5, which carries a non-contiguous extended bipartite nuclear localization signal. This signal comprises residues from at least three regions of the protein. We postulated that the introduction of this signal in the ribonuclease provides it w...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-010-9426-2
更新日期：2011-10-01 00:00:00
abstract：:Colon cancer is the third most malignant neoplasm in the world and it remains today an important cause of death, especially in western countries. In this study, we have evaluated the chemopreventive efficacy of morin on tissue lipid peroxidation and antioxidant status, which are used as biomarkers in 1,2-dimethylhydra...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-008-9136-1
更新日期：2009-02-01 00:00:00
abstract：:Antiprogestins have been largely utilized in reproductive medicine, yet their repositioning for oncologic use is rapidly emerging. In this study we investigated the molecular mediators of the anti-ovarian cancer activity of the structurally related antiprogestins RU-38486, ORG-31710 and CDB-2914. We studied the respon...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-011-9655-z
更新日期：2012-06-01 00:00:00
abstract：:Background C-Met, which is frequently activated in multiple cancers, has been implicated in tumor formation, progression, metastasis, angiogenesis, and resistance to multiple therapies. MK-8033 is a small-molecule inhibitor of c-Met that binds preferentially to the activated conformation, and has demonstrated anti-tum...
journal_title：Investigational new drugs
pub_type： 杂志文章,多中心研究
doi：10.1007/s10637-018-0567-z
更新日期：2018-10-01 00:00:00
abstract：:Sunitinib is an oral antityrosine kinase inhibitor that has antiangiogenic and antitumor activities. It has been approved for the treatment of advanced RCC and for imatinib-refractory gastrointestinal stromal tumors (GIST). Tumor lysis syndrom can occur in solid tumors. We report a case of patient with metastatic RCC ...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-009-9275-z
更新日期：2010-10-01 00:00:00
abstract：PURPOSE:Preclinical data indicate that combination HER2-directed and anti-VEGF therapy may bypass resistance to trastuzumab. A phase I trial was performed to assess safety, activity, and correlates. EXPERIMENTAL DESIGN:Patients with advanced, refractory malignancy were enrolled (modified 3 + 3 design with expansions f...
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pub_type： 杂志文章
doi：10.1007/s10637-014-0173-7
更新日期：2015-02-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-020-00941-2
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/BF00175378
更新日期：1984-01-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-010-9447-x
更新日期：2011-10-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-014-0168-4
更新日期：2015-02-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章,多中心研究,随机对照试验
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更新日期：2012-04-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/BF00944180
更新日期：1992-11-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-020-00950-1
更新日期：2020-12-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1023/a:1006260217400
更新日期：1999-01-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/BF00170866
更新日期：1989-07-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 临床试验,杂志文章,多中心研究
doi：10.1007/BF00216932
更新日期：1990-02-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章,评审
doi：10.1023/a:1006497231579
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-007-9093-0
更新日期：2008-06-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章,多中心研究
doi：10.1007/s10637-009-9363-0
更新日期：2011-04-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-009-9324-7
更新日期：2010-12-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章,评审
doi：10.1007/BF00873904
更新日期：1993-02-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-009-9375-9
更新日期：2011-04-01 00:00:00
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journal_title：Investigational new drugs
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doi：10.1007/BF00173781
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pub_type： 杂志文章
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更新日期：2016-12-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章,多中心研究,随机对照试验
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更新日期：2020-02-01 00:00:00
abstract：:Adrenocortical carcinoma (ACC) is an aggressive endocrine cancer with few molecular predictors of malignancy and survival, especially in paediatric patients. Stathmin 1 (STMN1) regulates microtubule dynamics and has been involved in the malignant phenotype of cancer cells. Recently, it was reported that STMN1 is highl...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-019-00846-9
更新日期：2020-06-01 00:00:00
abstract：:We investigated proliferation and apoptosis induction in Jurkat T-leukemia cells by the new isothiocyanate 4-(methylthio)butylisothiocyanate (MTBITC). To help elucidate whether the effects of MTBITC are specific for cancer cells, we tested MTBITC on freshly isolated, non-transformed human peripheral T lymphocytes. The...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1023/B:DRUG.0000011788.19754.54
更新日期：2004-04-01 00:00:00
abstract：:In vitro cytotoxicity and xanthine oxidase inhibition capabilities were investigated for five palladium (II) chelate complexes. The palladium complexes were synthesized by starting from S-alkyl-thiosemicarbazones where the alkyl component is methyl, ethyl, propyl or butyl. The solid complexes are characterized by elem...
journal_title：Investigational new drugs
pub_type： 杂志文章
doi：10.1007/s10637-019-00751-1
更新日期：2019-12-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 杂志文章
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更新日期：1985-01-01 00:00:00
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journal_title：Investigational new drugs
pub_type： 临床试验,杂志文章
doi：10.1007/s10637-017-0487-3
更新日期：2018-02-01 00:00:00
