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Personalized medicine in oncology: next generation

Nature Reviews Drug Discovery volume 10, pages 895–896 (2011)Cite this article

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Managing complexity and risk

The development of targeted drugs requires a number of decisions, in particular for clinical trial design and biomarker selection. Choosing to develop an agent with an established versus novel biomarker can affect the trade-offs between clinical and commercial risks. For example, the poly(ADP-ribose) polymerase (PARP) inhibitor iniparib (BSI-201; Sanofi/BiPar Sciences) was elected to undergo clinical trials in triple-negative breast cancers (established biomarkers), which are modestly correlated to breast cancer type 1 susceptibility protein (BRCA1) and BRCA2 mutations. PARP inhibition is thought to be ideally suited for BRCA1- and BRCA2-mutated breast and ovarian cancers, because of a mechanistic link between these mutations and DNA damage repair via PARP1. However, the failure of iniparib highlights the clinical risk of such a strategy, and follow-up studies in patients with BRCA mutations may be appropriate.

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Figure 1: Novel biomarker launch: issue map.

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Authors and Affiliations

  1. Alex Chiang and Ryan P. Million are at 675 Third Ave., 20th floor, New York 10017, New York, USA ,

    Alex Chiang & Ryan P. Million

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  1. Alex Chiang
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  2. Ryan P. Million
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Correspondence to Alex Chiang or Ryan P. Million.

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The authors declare no competing financial interests.

Supplementary information

Supplementary information S1

Projected sales of Xalkori and Zelboraf (millions of US dollars). (PDF 438 kb)

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Chiang, A., Million, R. Personalized medicine in oncology: next generation. Nat Rev Drug Discov 10, 895–896 (2011). https://doi.org/10.1038/nrd3603

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