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Regulatory Focus™ > News Articles > EMA Releases Guideline for Assessing Human Anticancer Products

EMA Releases Guideline for Assessing Human Anticancer Products

Posted 05 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency released a new guideline today titled, Guideline on the evaluation of anticancer medical products in man.

The guideline, adopted by the EMA during the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP), aims to provide guidance on the development of medicinal products for use in anti-cancer indications. 

More specifically, the guideline provides clarity on:

  • proper dosing of anticancer products
  • proper scheduling of anticancer products
  • optimizing the benefit of a product to patients by identifying the optimal target population
  • conducting studies on combination therapies

The guideline also explores EMA's thinking when it comes to defining an outcome as successful.

"Convincingly demonstrated favorable effects on overall survival (OS) are from both a clinical and methodological perspective the most persuasive outcome of a clinical trial," explains the guideline.

"Prolonged progression-free or disease-free survival (PFS/DFS), however, are in most cases as such considered relevant measures of patients benefit, but the magnitude of the treatment effect should be sufficiently large to outbalance toxicity and tolerability problems. In order to capture possible negative effects on the activity of next-line therapies and also treatment related fatalities, informative data on overall survival compatible with a trend towards favorable outcome are normally expected at time of submission."

The guideline should be read in conjunction with Directive 2001/83/EC and ICH S9, among other documents that are detailed within the guideline.

The guideline was released with an accompanying appendix, titled, Methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials, which provides guidance on endpoint definitions, frequency and methods of assessment, ascertainment bias, handling of deviations and missing data, and radiology review.

Consultations are due by 31 May, 2012.

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