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Review
. 2018 Mar;11(2):123-146.
doi: 10.1111/cts.12527. Epub 2017 Dec 19.

Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development

Stephanie Faucette  1 , Santosh Wagh  1 , Ashit Trivedi  2 , Karthik Venkatakrishnan  1 , Neeraj Gupta  1
Affiliations
Review

Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development

Stephanie Faucette et al. Clin Transl Sci. 2018 Mar.
No abstract available

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Figures

Figure 1
Figure 1
Timeline showing approvals of all NMEs included in the present analysis. ADC, antibody‐drug conjugate.
Figure 2
Figure 2
(a) Classification of the 56 oncology NMEs. (b) Initial labeling language for dosing instructions with respect to food intake for orally administered agents (n = 35). (c–e) Types of studies/analyses conducted to evaluate the potential for the NME to prolong the QTc interval in relation to the number of (c) total NMEs (n = 56), (d) small molecule (n = 39), and (e) large molecule (n = 17) agents. PMR, postmarketing requirement; TQT, thorough QT.
Figure 3
Figure 3
Summary of PMR/PMC studies requested for the 56 identified oncology NMEs across different types of clinical pharmacology evaluations. (Some NMEs had more than one PMR/PMC issued and so one NME may be counted in more than one bar.) CYP, cytochrome P450; DDI, drug‐drug interaction; QTc, corrected QT.
See this image and copyright information in PMC

References

    1. Gutierrez, M.E. , Kummar, S. & Giaccone, G. Next generation oncology drug development: opportunities and challenges. Nat. Rev. Clin. Oncol. 6, 259–265 (2009). - PMC - PubMed
    1. Bates, S.E. , Berry, D.A. , Balasubramaniam, S. , Bailey, S. , LoRusso, P.M. & Rubin, E.H . Advancing clinical trials to streamline drug development. Clin. Cancer Res. 21, 4527–4535 (2015). - PMC - PubMed
    1. Shaw, A.T. et al Ceritinib in ALK‐rearranged non‐small‐cell lung cancer. N. Engl. J. Med. 370, 1189–1197 (2014). - PMC - PubMed
    1. Prowell, T.M. , Theoret, M.R. & Pazdur, R. Seamless oncology‐drug development. N. Engl. J. Med. 374, 2001–2003 (2016). - PubMed
    1. Theoret, M.R. et al Expansion cohorts in first‐in‐human solid tumor oncology trials. Clin. Cancer Res. 21, 4545–4551 (2015). - PubMed

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