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Hurdles in anticancer drug development from a regulatory perspective

Nature Reviews Clinical Oncology volume 9, pages 236–243 (2012)Cite this article

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Abstract

Between January 2001 and January 2012, 48 new medicinal products for cancer treatment were licensed within the EU, and 77 new indications were granted for products already licensed. In some cases, a major improvement to existing therapies was achieved, for example, trastuzumab in breast cancer. In other cases, new fields for effective drug therapy opened up, such as in chronic myeloid leukemia, and renal-cell carcinoma. In most cases, however, the benefit–risk balance was considered to be only borderline favorable. Based on our assessment of advice procedures for marketing authorization, 'need for speed' seems to be the guiding principle in anticancer drug development. Although, for drugs that make a difference, early licensure is of obvious importance to patients, this is less evident in the case of borderline drugs. Without proper incentives and with hurdles inside and outside companies, a change in drug development cannot be expected; drugs improving benefit–risk modestly over available therapies will be brought forward towards licensure. In this Perspectives article, we discuss some hurdles to biomarker-driven drug development and provide some suggestions to overcome them.

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Figure 1: European Medicines Agency scientific advice procedures 2001–2010.

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Acknowledgements

The authors would like to acknowledge Francesco Pignatti of the European Medicines Agency, Oncology Sector and Jorge Martinalbo of the European Medicines Agency, Scientific Advice Sector for constructive discussions and expert search of databases. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

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Authors and Affiliations

  1. Läkemedelsverket (Medicinal Products Agency), P.O. Box 26, Uppsala, SE-751 03, Sweden

    Bertil Jonsson

  2. Department of Oncology and Pathology, Cancer Center Karolinska, Radiumhemmet, Karolinska Institutet and University Hospital, Stockholm, SE-171 76, Sweden

    Jonas Bergh

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Both authors made a substantial contribution to researching data for the article, discussion of content, and to writing and editing the manuscript before submission.

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Correspondence to Bertil Jonsson.

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Jonsson, B., Bergh, J. Hurdles in anticancer drug development from a regulatory perspective. Nat Rev Clin Oncol 9, 236–243 (2012). https://doi.org/10.1038/nrclinonc.2012.14

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