57% of cancer drugs uses approved by EMA show no benefit

pharmafile | October 5, 2017 | News story | Sales and Marketing EMA, biotech, drugs, oncology, pharma, pharmaceutical 

A new study conducted by King’s College London and LSE has found that of 48 treatments approved between 2009 and 2013 for 68 different indications, but 39 of these uses were found to be ineffective at boosting quality of life or improving survival on initial application.

The research then attempted to determine whether there were potential long-term benefits, beyond the short-term data supplied by the companies behind the drugs. In follow-up studies, after an average intervening period of five years, 49% still failed to show any significant quality or quantity of life benefit.

So, why did these drugs manage to obtain approvals? Many of the approvals were based on surrogate endpoints, despite these not being a reliable indicator of potential improvements to patients receiving the drugs.

Additionally, some treatments received conditional marketing authorisations with the expectation that the drug companies would return with confirmatory data from further trials.

However, the study identified 10 drugs that were approved under the fast track system and had been on the market for four years without evidence that they provided an extension to life or improved its quality.

Dr Courtney Davis, a medical and political sociologist in the Department of Global Health and Social Medicine at King’s College London, lead author of the study, said: “We evaluated the evidence base for all new drugs entering the market over a five year period and found that the majority came onto the market without clear evidence that they improved patients’ survival or quality of life. A large number of people are undergoing treatment for cancer and little new information is available to guide patients and their treating clinicians regarding drug effectiveness. When expensive drugs that lack robust evidence of clinical benefit are approved and reimbursed within publicly funded healthcare systems, individual patients may be harmed and public funds wasted.”

The findings raise major questions about the EMA’s approval process. In a number of cases, there is significant pressure on the agency and later on national regulatory bodies to approve cancer drugs due to desire to give patients options for treatment.

It has led to patient support group campaigns to advocate the approval of certain drugs, even when national bodies find the drug not to be cost-effective.

Ben Hargreaves

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