Development regulatory affairs for Oncology Medicinal Products

    /Adriaan  /Fruijtierspeaker of compliance global
    Speaker: Adriaan Fruijtier
    Duration: 60 Minutes
    Product Code: 700193
    Level: Beginner
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Because malignant tumours are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desirable to provide new, effective anticancer drugs to patients more expeditiously.

Therefore the requirements for non-clinical studies and clinical studies are different compared to other medicinal products. These are described in various guidelines.

Confirmatory clinical trials should be designed with the aim to establish the benefit - risk profile of the experimental medicinal product, including supportive measures, in a well-characterised target population of relevance for clinical practice.

The EMA uses three categories:

  • Reduced or similar toxicity
  • Increased toxicity and 
  • Major increase in toxicity

No precise definition is given due to heterogeneity of the conditions. ”Major increase in toxicity”, however, in most cases refers to a fear that the experimental regimen might be associated with an increase in treatment related deaths, irreversible adverse events with a long-term impact on quality of Life, or severe impairment to patient condition. The requirements in each of these categories are different.

why should you attend

Pre-clinical and clinical development in oncology is challenging for companies. After decades of drug development with highly toxic drugs and identification of the maximal tolerated dose as the major objective, targeted therapies come in the focus redefining benefit/risk ratio in this field. 

This webinar will explain why oncology is different, and where exactly the regulatory requirements differ.  

The EMA guideline on oncology treatment was adopted in 1996, and revised in 2001 and 2003, focused on conventional cytotoxic compounds. In 2005, a major revision was undertaken, aiming at covering non-cytotoxic compounds, to expand on the sections on exploratory trials and to provide more guidance with respect to methodological issues. Later, there followed an appendix on methodological issues related to use of PFS and in early 2010 an appendix on haematological malignancies followed. In this appendix disease specific guidance was introduced and the section on confirmatory studies based on aims of therapy and relative toxicity was restructured. 

In 2013, a new version of the guideline was issued. In this revision, the chapter on exploratory trials for cytotoxic compound has been shortened as it was considered too detailed and too prescriptive. The section on condition specific guidance (Appendix 4) has been expanded and now constitutes a separate Appendix. The EMA oncology guideline will be reviewed, as well as other applicable guidance documents, e g, on therapeutic cancer vaccines.

Approval for oncology drugs can be based on less data than in other therapeutic areas. The different procedures for faster approval at the EMA will be discussed, e.g. adaptive pathways and breakthrough designation.

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Areas Covered

The ICH S9 Guideline provides recommendations on the design and conduct of nonclinical studies to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options. Nonclinical evaluations are conducted to:

  • Identify the pharmacologic properties of a pharmaceutical,
  • Establish a safe initial dose level for the first human exposure, and
  • Understand the toxicological profile of a pharmaceutical (e.g., identification of target organs, exposure-response relationships, and reversibility).

In the development of cancer medications, clinical studies often involve cancer patients whose disease condition is progressive and fatal. In addition, the dose levels in these clinical studies often are close to or at the adverse effect dose levels. For these reasons, the type and timing and flexibility called for in designing of nonclinical studies of anticancer pharmaceuticals can have a different pattern from those for other pharmaceuticals.

For clinical trials there are several guidelines to take into account. Often approval with one pivotal study in a relatively small patient population is possible. For some malignancies where treatment is administered without curative intent, there are alternative, in good clinical practice still well established regimens, showing major differences in anti-tumour activity. This reflects that selection of therapy in the clinic is guided by efficacy and safety. It is therefore of relevance in the planning phase to take into account the expected tolerability/toxicity profile of the experimental regimen compared with the selected reference regimen. Safety data may be rather limited prior to the conduct of the first confirmatory trial, but main toxicities should normally have been identified and this should be sufficient for a rough estimate of the expected relative toxicity of the experimental regimen compared with alternative reference regimens. Other issues to take into account include risk for sign of secondary brain tumours.

This webinar will also discuss the benefits of scientific advice and possible faster approval pathways.

Learning Objectives

  • Understand how development in oncology is different
  • Knowledge of the main guidelines
  • Knowledge of faster approval pathways


  • Regulatory Affairs Personnel
  • Clinical trial associates
  • Clinical operations personnel
  • Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
  • Individuals who are seeking to update their knowledge of recent regulatory changes and their impact on product development


Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.

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