Abstract
The practical aspects of systemic radiotherapy development are a hybrid between that of more traditional oncology drug development and aspects of radiation oncology. Systemic radiotherapeutics (those directly administered in an unsealed source form) are drugs and are regulated as such whereas brachytherapy (sealed) sources are regulated as devices. The regulatory development path for drugs is well defined with some special provisions for oncology drugs. Systemic radiotherapeutics are accommodated by the existing regulations quite well but there are some differences. The regulations leading to drug approval are one of the major drivers of the differences between early academic or commercial development and later efforts. To understand these differences it is necessary to understand the effect of the drivers. This chapter will outline the pathways and the differences that are taken into consideration by pharma when developing a systemic radiotherapeutic agent.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Calvert AH, Plummer R (2008) The development of phase I cancer trial methodologies: the use of pharmacokinetic and pharmacodynamic end points sets the scene for phase 0 cancer clinical trials. Clin Cancer Res 14:3664–3669
CHMP (2007) Guideline on strategies to identify and mitigate risks for first in human trials with investigational medicinal products. EMEA/CHMP/SWP/294648/2007, Available at http://221.122.47.241/ccd/fs/web_edit_file/20070731113608.pdf
CPMP (1999) Note for guidance on the preclinical evaluation of anticancer medicinal products. CPMP/SWP/997/96, Available at www.emea.europa.eu/pdfs/human/swp/099796en.pdf
CPMP (2005) Guideline on the evaluation of anticancer medicinal products in man. CPMP/EWP/205/95/Rev.3/Corr.2, Available at http://www.ema.europa.eu/pdfs/human/ewp/020595en.pdf
Deweese TL, Shipman JF, Dillehay LE et al (1998) Sensitivity of human prostatic carcinoma cell lines to low dose rate radiation exposure. J. Urol 169:691–698
Doroshow JH, Parchment RE (2008) Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient. Clin Cancer Res 2008(14):3658–3663
EC (2009) Assessment of the function of the “Clinical Trials Directive” 2001/20/EC Public consultation paper. ENTR/F/2/SF D(2009) 32674, Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/clinicaltrials/docs/2009_10_09_public-consultation-paper.pdf
FDA (2004) Innovation or stagnation. Challenge and opportunity on the critical path to new medical products. Available at www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
FDA (2005) Draft guidance for industry. Nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals. Available at http://www.fda.gov/ohrms/dockets/98fr/2005d-0223-gd10001.pdf
FDA (2007) Guidance for industry clinical trial endpoints for the approval of cancer drugs and biologics. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf
FDA (2009) Running clinical trials. Guidances, information sheets, and notices, Available at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationsheetsandNotices/default.htm
Fleming TR (2005) Surrogate endpoints and FDA’s accelerated approval process the challenges are greater than they seem. Health Affair 24:67–78
Garcia-Barros M, Paris F, Cordon-Cardo C et al (2003) Tumor response to radiotherapy regulated by endothelial cell apoptosis. Science 300:1155–1159
ICH (2009) ICH M3(R2) Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Available at http://www.ich.org/cache/compo/276-254-1.html
Joiner MC, Marples B, Lambin P et al (2001) Low-dose hypersensitivity: Current status and possible mechanisms. Int J Radiat Oncol Biol Phys 49(2):379–389
OECD (1999) Organisation for economic co-operation and development. OECD Series on principles of good laboratory practice and compliance monitoring. Available at http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_1_1_1,00.html
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Nunn, A.D. (2012). Pharma Considerations for Timely Development of Therapeutic Radiopharmaceuticals. In: Baum, R. (eds) Therapeutic Nuclear Medicine. Medical Radiology(). Springer, Berlin, Heidelberg. https://doi.org/10.1007/174_2012_698
Download citation
DOI: https://doi.org/10.1007/174_2012_698
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-36718-5
Online ISBN: 978-3-540-36719-2
eBook Packages: MedicineMedicine (R0)