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EMA consults on biomarkers in cancer drug evaluation

Oncology medicine guideline changes also cover the use of companion diagnostics

The European Medicines Agency (EMA) is seeking views on proposed changes to the way it assesses cancer drugs.

Revisions to the regulator's Evaluation of Human Anticancer Medicines guidelines underline the importance of exploratory studies to properly define the most appropriate target population and puts further emphasis on the role of biomarkers.

“It is acknowledged that biomarkers tested in early clinical trials often were exploratory in nature, but it is essential that technical/quantitative reliability is assured,” the draft guidelines note.

The draft guidelines also cover companion diagnostics, and say their development should be considered early in clinical development, maximising the clinical application of the technology.

Pharma companies are increasingly looking to 'personalise' cancer drugs through the development of biomarkers and diagnostics to ensure they are used to treat the most appropriate patient population.

Earlier this week Pfizer signed a three-way deal with Roche subsidiary Ventana Medical Systems and Cell Signalling Technology to develop a companion diagnostic for its recently-approved lung cancer drug Xalkori.

But one of the best examples of how biomarkers can assist in the whole drug life cycle is Roche's Herceptin - which only benefits the 20 per cent of patients with Her2-positive breast cancers.

It's estimated the Swiss pharma company saved $35m in clinical trial costs and generated $2.5bn of income from the eight-year acceleration of Herceptin's approval that biomarkers made possible.

The EMA's Evaluation of Human Anticancer Medicines guidelines cover all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers and normal tissue protective compounds.

The original version of the guideline was adopted in 1996 and was last revised in early 2010 when disease specific guidance was introduced.

The latest proposed changes would add disease-specific guidance, including new guidance for lung cancer, prostate cancer and revised guidance for haematological malignancies.

There are also changes to appendix sections on methodological considerations for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials.

The human anticancer medicines guideline consultation on the next round of changes will run until May 31, 2012 and submissions can be made using the EMA's comments template

13th January 2012

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