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No clear evidence that most new cancer drugs extend or improve life

The majority of cancer drugs approved in Europe between 2009 and 2013 entered the market without clear evidence that they improved patient survival or quality of life, a new study suggests.

The majority of cancer drugs approved in Europe between 2009 and 2013 entered the market without clear evidence that they improved patient survival or quality of life, a new study suggests.


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Even where drugs did show survival gains over existing treatments, these were often marginal, the results show.

Many of the drugs were approved on the basis of indirect (‘surrogate’) measures that do not always reliably predict whether a patient will live longer or feel better, raising serious questions about the current standards of drug regulation, the authors suggest.

Researchers at King’s College London and the London School of Economics analysed reports on cancer approvals by the European Medicines Agency (EMA) from 2009-2013.

Of 68 cancer indications approved, 57% (39) came onto the market on the basis of a surrogate endpoint and without evidence that they extended survival or improved the quality of patients' lives.

After a median of five years on the market, only an additional eight drug indications had shown survival or quality of life gains.

Out of 68 cancer indications approved by the EMA, and with a median 5 years follow-up, only 35 (51%) had shown a survival or quality of life gain over existing treatments or placebo. For the remaining 33 (49%), uncertainty remains over whether the drugs extend survival or improve quality of life.

The researchers say their findings raise the possibility that regulatory evidence standards 'are failing to incentivise drug development that best meets the needs of patients, clinicians, and healthcare systems'.


Davis C et al (2017). Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ. doi: https://doi.org/10.1136/bmj.j4530

 

 

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