A new report by The Institute of Cancer Research, London (ICR) has revealed an increase of nearly one year in delay between clinical trials, regulatory approvals and patient access to new cancer medications.
Titled ‘From patent to patient – analysing access to innovative cancer drugs’, the report analysed all 97 cancer drugs licensed by the European Medicines Agency (EMA) for 177 indications between 2000 and 2016.
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The rate of drug authorisations was observed to have risen nearly two-fold between 2000 and 2016.
However, the average time from the start of Phase I clinical trials to EMA marketing authorisation increased to 9.1 years in 2009-2016 from 7.8 years in 2000-2008.
In addition, the average time from when a cancer drug is patented to its approval by UK’s National Institute for Health and Care Excellence (NICE)for patients in the NHS, increased to 14.1 years in 2009-2016 from 12.7 years in 2000-2008.
ICR noted that NICE’s effort to reduce the time taken for drugs to reach patients by initiating early appraisals has not been sufficient.
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By GlobalDataNICE is said to have focused on low-innovation drugs, which comprised 53% of its approvals for EMA authorisations. On the contrary, NICE approved only 38% of high-innovation drugs.
The report further revealed huge differences in development rates of new drugs for various types of cancer, with 15 drugs being licensed for breast cancer from 2000 to 2016, but zero for brain tumours.
Of the 177 drug authorisations, only ten were related to paediatric cancer indications. Only two of these approvals were for solid tumours that constitute approximately 60% of new childhood cancer cases each year.
ICR chief executive Paul Workman said: “Our analysis gives us a vivid picture of the state of the nation in cancer drug discovery, development, licensing and appraisal.
“The future of cancer drug development lies in smaller, smarter, streamlined clinical trials, so it is frustrating to see the journey to patients slowing down when it should be speeding up.
“We need genuinely novel drugs that deliver step-change benefits either on their own or in combination – in order to meet the major clinical challenge of cancer evolution and drug resistance.”
The research institute is calling on the government, regulators and pharmaceutical companies to jointly work towards speeding up the development of innovative cancer treatments.
