Companion diagnostics and the drug-diagnostic codevelopment model

Drug Development Research

Volumn 73, Issue 7, 2012, Pages 390-397

  Jørgensen, Jan Trøst ^a  

^a Dx Rx Institute   (Denmark)

Author keywords

clinical utility; clinical validation; companion diagnostics; drug diagnostic codevelopment; oncology; personalized medicine

Indexed keywords

ANASTROZOLE; BIOLOGICAL MARKER; CETUXIMAB; CRIZOTINIB; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ERLOTINIB; ESTROGEN RECEPTOR; EXEMESTANE; GEFITINIB; IMATINIB; LAPATINIB; LETROZOLE; PANITUMUMAB; PERTUZUMAB; TAMOXIFEN; TAMOXIFEN CITRATE; TRASTUZUMAB; VEMURAFENIB;

BREAST CANCER; CANCER PATIENT; CLINICAL STUDY; COMPANION DIAGNOSTIC; DIAGNOSTIC TEST; DRUG DIAGNOSTIC CODEVELOPMENT MODEL; DRUG EFFICACY; HUMAN; LUNG NON SMALL CELL CANCER; PHARMACOLOGICAL PARAMETERS; PREDICTIVE VALUE; REVIEW; SENSITIVITY AND SPECIFICITY; SOLID TUMOR; TREATMENT OUTCOME; TREATMENT RESPONSE; VALIDATION PROCESS;

EID: 84870052768     PISSN: 02724391     EISSN: 10982299     Source Type: Journal    
DOI: 10.1002/ddr.21029     Document Type: Review

References (37)

1. Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, et al.; CLEOPATRA Study Group. 2012. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 366: 109-119.
2. Brügmann A, Sorensen BS,. 2011. Identifying responders to trastuzumab therapy in breast cancer. Future Oncol 7: 767-773.
3. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, et al.; BRIM-3 Study Group. 2011. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 364: 2507-2516.
4. Chin L, Hahn WC, Getz G, Meyerson M,. 2011. Making sense of cancer genomic data. Genes Dev 25: 534-555.
5. Chustecka Z,. 2012. Slew of targeted cancer drugs on the way. Medscape Medical News, March 1, 2012. http://www.medscape.com/viewarticle/759523 Accessed 2 April 2012.
6. Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, et al. 2002. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347: 472-480.
7. EMA. 2010. Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development. Draft. 24 June 2010. EMA/CHMP/641298/2008. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2010/07/WC500094445.pdf Accessed 12 March 2012.
8. EMA. 2011. Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection. Draft. 9 June 2011. EMA/CHMP/917570/2011. http://www.ema.europa.eu/ docs/en-GB/document-library/Scientific-guideline/2011/07/WC500108672.pdf Accessed 12 March 2012.
9. FDA. 2005. Drug-diagnostic co-development concept paper. Draft. Food and Drug Administration (FDA) April 2005. http://www.fda.gov/downloads/Drugs/ ScienceResearch/ResearchAreas/Pharmacogenetics/UCM116689.pdf Accessed 12 March 2012.
10. FDA. 2010. US FDA presentation to the Oncology Drugs Advisory Committee, 22 March 2010. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM206085.pdf Accessed 3 April 2012.
11. FDA. 2011. In vitro companion diagnostic devices. Draft Guidance. FDA, 14 July 2011. http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf Accessed 12 March 2012.
12. Gerlinger M, Rowan AJ, Horswell S, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, et al. 2012. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 366: 883-892.
13. Giltnane JM, Molinaro A, Cheng H, Robinson A, Turbin D, Gelmon K, Huntsman D, Rimm DL,. 2008. Comparison of quantitative immunofluorescence with conventional methods for HER2/neu testing with respect to response to trastuzumab therapy in metastatic breast cancer. Arch Pathol Lab Med 132: 1635-1647.
14. Gomez HL, Doval DC, Chavez MA, Ang PC, Aziz Z, Nag S, Ng C, Franco SX, Chow LW, Arbushites MC, et al. 2008. Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J Clin Oncol 26: 2999-3005.
15. Jørgensen JT,. 2008. Are we approaching the post blockbuster era? - pharmacodiagnostics and rational drug development. Expert Rev Mol Diagn 8: 689-695.
16. Jørgensen JT,. 2010. Targeted HER2 treatment in advanced gastric cancer. Oncology 78: 26-33.
17. Jørgensen JT,. 2011. A challenging drug development process in the era of personalized medicine. Drug Discov Today 16: 891-897.
18. Jørgensen JT, Møller S, Rasmussen BB, Winther H, Schønau A, Knoop A,. 2011. High concordance between two companion diagnostics. A concordance study between the herceptest and the HER2 FISH pharmDx kit. Am J Clin Pathol 136: 145-151.
19. Jørgensen JT, Nielsen KV, Ejlertsen B,. 2007. Pharmacodiagnostics and targeted therapies - a rational approach for individualizing medical anti-cancer therapy in breast cancer. Oncologist 2: 397-405.
20. Jørgensen JT, Winther H,. 2010. The development of the herceptest - from bench to bedside. In:, Jørgensen JT, Winther H, editors. Molecular diagnostics - the key driver of personalized cancer medicine. Singapore: Pan Stanford Publishing, p 43-60.
21. Kelloff GJ, Sigman CC,. 2012. Cancer biomarkers: selecting the right drug for the right patient. Nat Rev Drug Discov 11: 201-214.
22. Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Jänne PA, Costa DB, et al. 2010. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 363: 1693-1703.
23. La Thangue NB, Kerr DJ,. 2011. Predictive biomarkers: a paradigm shift towards personalized cancer medicine. Nat Rev Clin Oncol 8: 587-596.
24. Lehár J, Krueger A, Zimmermann G, Borisy A,. 2008. High-order combination effects and biological robustness. Mol Syst Biol 215: 1-6.
25. Lerner HJ, Band PR, Israel L, Leung BS,. 1976. Phase II study of tamoxifen: report of 74 patients with stage IV breast cancer. Cancer Treat Rep 60: 1431-1435.
26. Lesko LJ, Zineh I, Huang SM,. 2010. What is clinical utility and why should we care? Clin Pharmacol Ther 88: 729-733.
27. Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, et al. 2009. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361: 947-957.
28. Ou SH,. 2011. Crizotinib: a novel and first-in-class multitargeted tyrosine kinase inhibitor for the treatment of anaplastic lymphoma kinase rearranged non-small cell lung cancer and beyond. Drug Des Devel Ther 5: 471-485.
29. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, et al.; Herceptin Adjuvant (HERA) Trial Study Team. 2005. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 353: 1659-1672.
30. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, et al. 2005. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353: 1673-1684.
31. Scherf U, Becker R, Chan M, Hojvat S,. 2010. Approval of novel biomarkers: FDA's perspective and major requests. Scand J Clin Lab Invest Suppl 242: 96-102.
32. Schilsky RL,. 2011. Drug approval challenges in the age of personalized cancer treatment. Pers Med 8: 633-640.
33. Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S,. 2010. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist 15: 122-129.
34. Simon R, Maitournam A,. 2004. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 10: 6759-6763.
35. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, et al. 2001. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344: 783-792.
36. Winther H, Jørgensen JT,. 2010. Drug-diagnostic co-development in cancer. Pharm Med 24: 363-375.
37. Woodcock J,. 2010. Assessing the clinical utility of diagnostics used in drug therapy. Clin Pharmacol Ther 88: 765-773.