COMMENT

Moving upstream in anticancer drug development

The development of oncology drugs traditionally begins by studying them in heavily pretreated patients, and then working ‘upstream’ to populations with earlier-stage disease. The recent FDA approval of an androgen receptor antagonist first in prostate cancer patients without demonstrable metastatic disease but at high-risk for metastasis, based on a novel metastasis-free survival end point developed by the FDA, could provide a template for a paradigm shift.
External Innovation, Johnson & Johnson, New Brunswick, NJ, USA.
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Janssen Oncology, Janssen Research and Development, Spring House, PA, USA.

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Nature Reviews Drug Discovery 18, 159-160 (2018)

doi: 10.1038/d41573-018-00006-3

References

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    Beaver, J. A., Kluetz, P. G. & Pazdur, R. Metastasis-free survival – a new end point in prostate cancer trials. N. Engl. J. Med. 378, 2458–2460 (2018).

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    Smith, M. R. et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N. Engl. J. Med. 378, 1408–1418 (2018).

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    Hussain, M. et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N. Engl. J. Med. 378, 2465–2474 (2018).

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    de Bono, J. S. et al. Abiraterone and increased survival in metastatic prostate cancer. N. Engl. J. Med. 364, 1995–2005 (2011).

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    Ryan, C. J. et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N. Engl. J. Med. 368, 138–148 (2013).

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Competing Financial Interests

W.N.H. is an employee of J&J and former head of Janssen R&D. P.F.L. is an employee and stockholder of J&J/Janssen R&D.

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