Emerging Therapies in Metastatic Castration-Resistant Prostate Cancer: A Regulatory Perspective
DOI:
https://doi.org/10.12974/2309-6160.2013.01.01.3Keywords:
Abiraterone acetate, Cabazitaxel, Docetaxel, Enzalutamide, regulatory aspects.Abstract
Worldwide, prostate cancer (PC) is the most commonly diagnosed cancer and the second cause of cancer death in men. During the past decade, metastatic prostate cancer patients were usually treated with androgen deprivation therapy (ADT), and once they progressed to a castration-refractory disease status docetaxel-based chemotherapy was the main option. Recently, the therapeutic armamentarium for the treatment of patients with metastatic castration-resistant prostate cancer has been shaken with the appearance of new attractive pharmacological therapies. New treatments have shown benefits in the progression free survival and the life expectancy with an acceptable and, in general terms, a rather manageable safety profile. This review is aimed to describe how new emerging therapies in metastatic castration-resistant prostate cancer have obtained the marketing authorisations in Europe and to discuss on the imminent challenges to be faced due to the changes in the treatment paradigm/strategy for prostate cancer.
References
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin 2013; 63(1): 11-30. http://dx.doi.org/10.3322/caac.21166
International Agency for Research on Cancer (IARC). GLOBOCAN 2008 Database: Summary Table by Cancer. Available at http://www-dep.iarc.fr/. (Accessed June 25, 2013).
Tewari R, Rajender S, Natu SM, Dalela D, Goel A, Goel MM, et al. Diet, obesity, and prostate health: are we missing the link? J Androl 2012; 33(5): 763-76. http://dx.doi.org/10.2164/jandrol.111.015578
Huggins C, Hodges CV. The effect of castration, of estrogens, and of androgen injection on serum phosphatase in metastatic carcinoma of prostate. Cancer Res 1941; 1: 293-97.
Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, et al. EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2011; 59(4): 572-83. http://dx.doi.org/10.1016/j.eururo.2011.01.025
NCCN clinical practice guidelines in oncology. Prostate cancer. Version 2.2013. http://www.nccn.org/professionals/ physician_gls/pdf/prostate.pdf. (accessed June 25, 2013).
Horwich A, Parker C, Bangma C, Kataja V. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010; 21(Supplement 5): v129- v133.
Petrylak DP, Tangen CM, Hussain MHA, et al. Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer. N Engl J Med 2004; 351: 1513-20.
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351: 1502-12.
European Medicines Agency. Zytiga Product Information. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medici nes/human/medicines/002321/human_med_001499.jsp&mid =WC0b01ac058001d124. (accessed June 25, 2013).
Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10; 368(2): 138-48.
European Medicines Agency. Zytiga (EMEA/H/C/002321/ II/0004/G) European Public Assessment Report. http://www. ema.europa.eu/docs/en_GB/document_library/EPAR_- _Assessment_Report_-_Variation/human/002321/ WC500137814.pdf. (accessed June 25, 2013).
Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008; 26(7): 1148-59.
European Medicines Agency. Jevtana Product Information. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medici nes/human/medicines/002018/human_med_001428.jsp&mid =WC0b01ac058001d124 (accessed June 25, 2013).
de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010; 376(9747): 1147-54.
European Medicines Agency. Jevtana European Public Assessment Report. http://www.ema.europa.eu/docs/ en_GB/document_library/EPAR_-_Public_assessment_ report/human/002018/WC500104766.pdf (accessed June 25, 2013)
de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011; 364(21): 1995-2005.
European Medicines Agency. Zytiga (EMEA/H/C/002321) European Public Assessment Report. http://www.ema. europa.eu/docs/en_GB/document_library/EPAR_- _Public_assessment_report/human/002321/WC500112860.p df (accessed June 25, 2013).
European Medicines Agency. CHMP summary of positive opinion for Xtandi. http://www.ema.europa.eu/docs/en_GB/ document_library/Summary_of_opinion_-_Initial_authorisation/ human/002639/WC500142493.pdf. (accessed June 25, 2013).
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012; 367(13): 1187-97.
Lassi K, Dawson NA. Update on castrate-resistant prostate cancer: 2010. Curr Opin Oncol 2010; 22(3): 263-7.
Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004; 351(15): 1513-20.
Scher HI, Warren M, Heller G. The association between measures of progression and survival in castrate-metastatic prostate cancer. Clin Cancer Res 2007; 13: 1488-92.
Fleming TR, Rothmann MD, Lu HL. Issues in using progression-free survival when evaluating oncology products. J Clin Oncol 2009; 27: 2874-80.
Armstrong AJ, Febbo PG. Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature. Oncologist 2009; 14(8): 816-27.
Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al. Sipuleucel-T immunotherapy for castrationresistant prostate cancer. N Engl J Med 2010; 363(5): 411- 22.
U.S. Food and Drug Administration. Approval Letter - Provenge. http://www.fda.gov/BiologicsBloodVaccines/ CellularGeneTherapyProducts/ApprovedProducts/ucm21021 5.htm. (accessed June 25, 2013).
U.S. Food and Drug Administration. Approved drugs - Radium Ra 223 dichloride. http://www.fda.gov/Drugs/ InformationOnDrugs/ApprovedDrugs/ucm352393.htm. (accessed June 25, 2013).
Noonan KL, North S, Bitting RL, Armstrong AJ, Ellard SL, Chi KN. Clinical activity of abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after enzalutamide. Ann Oncol 2013.
Clinical trials web page. A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients. http://www.clinicaltrials.gov/ ct2/results?term=NCT01650194&Search=Search. (accessed June 25, 2013).
