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An accelerated pathway for targeted cancer therapies

Abstract

A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers.

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References

  1. US FDA. Drug–Diagnostic Co-Development Concept Paper. FDA website [online], (2005).

  2. Mandrekar, S. J. & Sargent, D. J. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J. Clin. Oncol. 27, 4027–4034 (2009).

    Article  Google Scholar 

  3. Hoering, A. et al. Randomized phase III clinical trial designs for targeted agents. Clin. Cancer Res. 14, 4358–4367 (2008).

    Article  CAS  Google Scholar 

  4. Simon, R. & Maitournam, A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin. Cancer Res. 10, 6759–6763 (2004).

    Article  CAS  Google Scholar 

  5. Jiang, W. et al. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. J. Natl Cancer Inst. 99, 1036–1043 (2007).

    Article  Google Scholar 

  6. Barker, A.D. et al. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin. Pharmacol. Ther. 86, 97–100 (2009).

    Article  CAS  Google Scholar 

  7. Goodsaid, F. M. et al. Strategic paths for biomarker qualification. Toxicology 245, 219–223 (2008).

    Article  CAS  Google Scholar 

Download references

Acknowledgements

P. Keegan of the US FDA provided comments on a draft. E. Karnes, M. Morrison, R. Anderson and E. Khoong of the Brookings Institution, and L. Fahey McGrath of Novartis, contributed to background research and assisted in drafting. The recommendations are based on a discussion at the Conference on Cancer Clinical Research, 14 September 2009, hosted by the Brookings Institution and Friends of Cancer Research.

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Correspondence to Joshua Benner.

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David Epstein is CEO of novartis Oncology. Richard Schilsky has served on the scientific advisory board of Foundation medicine. Joshua Benner, Cindy Geoghegan, Stephen Friend, David Kessler, Mark McClellan, David Sidransky and Ray Woosley declare no competing financial interests.

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McClellan, M., Benner, J., Schilsky, R. et al. An accelerated pathway for targeted cancer therapies. Nat Rev Drug Discov 10, 79–80 (2011). https://doi.org/10.1038/nrd3360

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