Literature DB >> 29882302

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers.

Kenji Yamashita1,2, Masayuki Kaneko1, Mamoru Narukawa1.   

Abstract

Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown. We analyzed the anticancer drugs approved in Japan from 2006 to 2016 to compare the drug approval lag based on cancer incidence (major vs. minor cancers) between Japan and the United States. The lag of anticancer drugs for minor cancers had not decreased relative to that a decade ago. Recently, development strategies resulting in longer approval lag were used by pharmaceutical companies more often for the development of drugs used to treat minor cancers than for drugs targeting major cancers, leading to significant differences in the approval lag time between drugs for major and minor cancers. Effective measures that expedite the development of drugs targeting minor cancers in Japan should, therefore, be implemented to shorten lag time.
© 2018 American Society for Clinical Pharmacology and Therapeutics.

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Year:  2018        PMID: 29882302     DOI: 10.1002/cpt.1136

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  6 in total

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Authors:  Jennifer E Miller; Michelle M Mello; Joshua D Wallach; Emily M Gudbranson; Blake Bohlig; Joseph S Ross; Cary P Gross; Peter B Bach
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4.  Where Can Patients Obtain Information on the Preapproval Access Pathway to Investigational Treatment in Japan? A Survey of Patient Advocacy Organizations' Websites.

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5.  An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018).

Authors:  Mahanjit Konwar; Mitesh R Maurya; Tushar B Nishandar; Urmila M Thatte; Nithya J Gogtay
Journal:  Perspect Clin Res       Date:  2021-01-08

6.  MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial.

Authors:  Hitomi S Okuma; Kan Yonemori; Shoko N Narita; Tamie Sukigara; Akihiro Hirakawa; Toshio Shimizu; Taro Shibata; Akira Kawai; Noboru Yamamoto; Kenichi Nakamura; Toshiro Nishida; Yasuhiro Fujiwara
Journal:  Clin Pharmacol Ther       Date:  2020-04-07       Impact factor: 6.875

  6 in total

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