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Over half of cancer drugs approved for use in the UK in recent years are not proven to extend life, according to a study. Even where drugs did show survival gains over existing treatments, these were often marginal, the results published in the British Medical Journal (BMJ) 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, researchers said.
"When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined," they said.
The research team based at King's College London and the London School of Economics in the UK analysed reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Of 68 cancer indications approved during this period, 57 per cent (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, researchers said.
After a median of five years on the market, only an additional eight drug indications had shown survival or quality of life gains, they said. Out of 68 cancer indications approved by the EMA, and with a median five years follow-up, only 35 (51 per cent) had shown a survival or quality of life gain over existing treatments or placebo. For the remaining 33 (49 per cent), uncertainty remains over whether the drugs extend survival or improve quality of life.
The 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."