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Europe’s cancer drug regulation is ‘broken’, claims study

Suggests EMA oncology approvals could lead to wasted funds and patient harm


A new study has suggested that 57% of cancer drug uses approved by the European Medicines Agency (EMA) between 2009 and 2013 do not provide survival or quality-of-life benefits.

Most drugs are approved on the basis of surrogate markers and - according to the authors of the study - after a minimum of three years on the market and an average of five in 49% of cases “there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications”.

All told, there were 48 cancer drugs approved for 68 indications during the period, and evidence for improved survival at the time of approval was present in 35% of cases, with quality-of-life benefits seen in 10%, say the researchers from King’s College London and the London School of Economics (LSE).

Moreover, of the 23 drugs that actually improved survival, nearly half (11) failed to meet the European Society of Medical Oncology’s definition of a ‘clinically meaningful benefit’, and the study concludes that the low bar “is failing to incentivise drug development that best meets the needs of patients, clinicians, and healthcare systems”.

Lead author Courtney Davis, a medical and political sociologist at King’s, said: “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 suggest that the current practice of approving drugs based on biomarkers is flawed, as these surrogate endpoints are unreliable and “the strength of association between surrogates in cancer clinical trials and life extension is generally low”.

An editorial accompanying the study by Vinay Prasad, assistant professor of medicine at Oregon Health and Science University in the US, says the findings are in line with another assessment looking at FDA approvals between 2008 and 2012.

“The expense and toxicity of cancer drugs means we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life,” he said. The findings suggest “we may be falling far short of this important benchmark”, he added.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) agreed it is ‘critical’ to assess the value and performance of new cancer medicines, but noted that the study mainly focuses on “clinical trials rather than real world data on actual patient outcomes”.

It added: “To help determine how medicines will function in a real world setting surrogate endpoints - often laboratory tests indicative of an expected improvement - often employed as clinical endpoints are less clear-cut in more complexes diseases such as cancer.”

Additionally, EFPIA says that studies in cancer are ‘disease-specific’ and survivability rates are dependent on tumour types, therefor clinicians need treatment options to “individualise care to the patient”.

Meanwhile, medical charity Cancer Research UK said the findings were “useful” but director of policy Emma Greenwood cautioned that the study “might not reflect the drugs that are available in the UK as it has another layer of approval for drugs” in the form of appraisal by the National Institute for Health and Care Excellence (NICE). She also said the system has changed since the period under study.

Article by
Phil Taylor

6th October 2017

From: Regulatory



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