Tech Review

Companion Diagnostics – meeting scientific and regulatory needs

06.03.2012

The majority of drugs are currently prescribed empirically, but advances in research focusing on the molecular mechanisms of specific diseases have opened new pathways to matching patients with drugs that are more likely to be effective and safe. The term ‘personalised medicine’ is currently used to summarise different levels of this process. The route to approval for a drug/diagnostic combination, however, continues to be rocky.

In extreme cases, individualised medicines vary from patient to patient. Such therapeutic concepts include, for example, cell-based cancer vaccines. A less extreme level of personalisation is the concept of stratified medicine. Here, a patient can be classified according to a specific cohort that shows an efficient differential response to a given drug. This stratification is achieved through the use of a clinical biomarker that has been correlated to a differential response.

Improving on empirical medicine

To be implemented in stratified medicine as a companion diagnostic, a clinical bio­marker should be predictive for the efficacy and safety of the treatment. The most frequently-used predictive clinical biomarker concepts at the moment include techniques such as gene-expression pattern, individual protein expression (on histology) and even imaging. A stratified medicine regime adds a clinical bio­marker assessment to empirical medicine practice, and associates a patient with the best thera­py available with respect to efficacy and safety. That helps to avoid treatments with toxic side effects and low or even no benefit for the patient. For the application of stratified medicine, the following three pre­requisites are required: I) underlying disease with variability reflecting multifactorial aetiology, II) multiple treatment options and III) a predictive clinical biomarker.

Cetuximab – a pioneer in the field

Successful anti-cancer treatment requires not only a potent drug, but also finding the right drug for a specific patient in a timely manner. The concept of stratified medicine has so far therefore focused on cancer treatment where both quality and time are critical. In 2004, the approval of Cetuximab by the US Food & Drug Administration (FDA) added another option for the treatment of colorectal cancer through chemotherapy. However, subsequent clinical experience indicated benefit for patients in only 10 -20% of the cases. In the years that followed, an intensive search for a predictive bio­marker led to stratification of the treatment with Cetux­imab. Retrospective analysis revealed a lack of benefit associated with Cetuximab treatment in colo­rectal cancer patients harboring mutations in the KRAS gene. These studies resulted in a label restriction from both the FDA and the EMA (in 2009) for patients without a KRAS mutation. In Europe, a diagnostic test for detection of the KRAS mutation recently (2011) received a CE label.
Making the case-by-case decision
Despite the fact that retrospective clinical biomarker analysis with subsequent development of companion diagnostic tests remains common practice, both the EMA and FDA favor co-development of drug and diagnostic. The concept of co-development envisages the approval of a diagnostic test at the time of drug approval. One of the most important consequences of this concept is that screening for suitable predictive bio­markers should occur at a very early stage of drug development, with implementation of the biomarker hypothesis in clinical trial design. In recent years, both the EMA and FDA have noted the need for regulations and clear concepts to support the development of stratified/personalised medicines along with appropriate diagnostic tests. However, in Europe the situation remains uncertain. Most importantly, current regulations and concept papers do not allow for a coordinated approval of a drug and its associated companion diagnostic. And in contrast to the situation in the US, cross-labeling of drug and companion diagnostics in Europe is not required. Additionally, self-certification by IVD manufacturers and a lack of harmonised quality regulations in clinical laboratories providing companion diagnostic testing may serve to widen the quality window of test results. Overall, the current regulatory landscape in Europe and in the US implements a case-by-case approach for the development of companion diagnostics that is in line with the advice for a very early consultation with the regulatory agency.

Politics / Law

23.03.2012

Brussels/Strasbourg – Health claims are set to be drastically limited in the EU. On Wednesday 21 March the Environment Committee of the European Parliament confirmed a proposal of the European Commission to prohibit 1,600 health...

Politics / Law

15.03.2012

Parma/Stockholm – Foodborne bacteria such as Salmonella and Campylobacter are becoming more and more resistant to antimicrobial drugs, according to a joint report published by the European food watchdog EFSA and the European...

BioFunding

09.03.2012

In mid-February, scientists and entrepreneurs from nine EU countries met at the Center for Genomic Regulation (CRG) in Barcelona to launch the 4DCellFate project. Positioned within the FP7 Programme, the consortium will receive...

BioFunding

09.03.2012

Brussels – The EU’s Innovative Medicines Initiative (IMI) will establish the European Lead Factory, an EU-wide public-private partnership aiming to facilitate drug discovery efforts. The Lead Factory will comprise a...

Editorial

07.03.2012

T    he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the...

Tech Review

07.03.2012

Intellectual Property (IP) is without question one of the most vital aspects of any bio­tech venture, a key and undisputed factor for success. However, most bio­tech companies are still incapable of unlocking the value of their...

Clinical Trial

07.03.2012

Schlieren – Swiss Cytos Biotechnology Ltd. has been authorised to restructure a convertible bond by Canton of Zurich authorities. The company does not have enough cash to pay it back. Negotiations with bond holders failed in a...

Clinical Trial

06.03.2012

Munich – German 4SC AG jumped 39% to €2.05/share after oncology drug candidate resminostat met the primary endpoint of at least a 20% progression-free survival rate in a Phase II trial to treat patients with hepatocellular...

Editorial

06.03.2012

The start of 2012 witnessed the tides turning in favour of small and mid-cap names in the European Life Sciences sector. Major global biotechnology indices like the NBI, BTK, and BIOTK are up over 15% year to date. The pace of...

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