Regulatory Focus™ > News Articles > EMA Releases Revised Anticancer Products Guideline

EMA Releases Revised Anticancer Products Guideline

Posted 15 January 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has released an updated scientific guideline it says will make it easier for sponsors of oncology and other anticancer medicines to conduct clinical trials.

The guideline, On the evaluation of anticancer medicinal product in man, released 11 January 2013, is primarily focused on the clinical development of drug products, and has two main revisions relative to its previous 2010 edition.

First, EMA has cut out much of its previous chapter on exploratory trials for cytotoxic compounds, saying it was "considered too detailed and too prescriptive."

More importantly, however, it has expanded its condition-specific guidance, which now constitutes a separate appendix on five types of cancer: non-small cell lung cancer (NSCLC), prostate cancer, chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS) and haematopoetic stem cell transplantation (HSCT).

All five are given a general framework under which they can expect to receive approval from EU regulators, along with some more specific considerations relative to each type of cancer.

The recommendations are part of EMA's broader guideline, which describes the process by which many anticancer drugs come to market. The key, write EMA regulators, is for sponsors to be prepared to justify whatever interim analyses they conduct on a product.

"Convincingly demonstrated favorable effects on overall survival (OS) are from both a clinical and methodological perspective the most persuasive outcome of a clinical trial," the guideline explains. However, progression-free survival and disease-free survival metrics are often substitutable on an interim basis for other endpoints, though regulators caution that the benefit must be clear and not outweighed by toxicity or tolerability issues.

Regulators will then generally follow up with the drug's sponsor at a pre-determined time after its approval to receive a full accounting of the trial data and whether the resulting data still supports and approval decision. In the US, such reviews have been sufficient to lead to the withdrawal of some oncology medications, including Roche's Avastin (bevacizumab), though that case is admittedly rare.


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