A recent study has found that only 43% of cancer drugs recently approved in Europe allowed patients to live longer, or improved their quality of life.
48 new cancer drugs were approved in Europe between 2009 and 2013, for the treatment of 68 cancer indications.
The study, which was published in the British Medical Journal (BMJ), examined the effectiveness of these drugs compared with existing treatments, and revealed that only 23 indications showed evidence of an improved survival rate, and only 11 of these had clinically meaningful benefits related to survival and quality of life.
Calls for improved clinical testing
This study highlights the gulf between preclinical testing and the measures used to assess cancer drugs over the long term.
Most early clinical trials focus on indirect methods to judge effectiveness – such as biomedical imaging for tumor reduction, and laboratory tests – and the study indicates that these may not be suitable for the calculation of long-term patient benefits.
Huseyin Naci, a professor at the London School of Economics and a co-author of the study, said: “It is remarkable that so few cancer drugs enter the European market without any clear data on outcomes that matter to patients and their doctors: longer survival and better quality of life.”
The authors suggest that European regulators may be placing too much emphasis on fast approvals, concluding that the EMA’s standards “fail to incentivize drug development that best meets the needs of patients, clinicians and healthcare systems”. The EMA has yet to fully analyze the study’s findings, and a full statement has not been released.
However, a spokesperson for the organization stated that the EMA “welcomes further debate” on the subject, and “has discussed the evidence underpinning cancer medicines widely”.
So what could be done by regulators to ensure that new drugs actually improve patients’ quality of life and long-term outlook?
Firstly, the EMA may look to instigate long-term patient studies following drug approval to assess whether patient benefits match those measured in laboratory testing.
Similarly, national bodies such as Nice (the National Institute for Health and Care Excellence) in the UK may need to invest more time into assessing cancer therapeutics.
Within the UK, NICE reviews all new cancer drugs within 90 days of their approval for licensing, to determine whether they are appropriate for use on the NHS, and longer assessment periods would enable more accurate decision making.
Promising drugs with limited available data could also be marketed through the Cancer Drugs Fund, while more evidence is collected and before a final decision is made.
These types of measures, alongside stricter regulations on drug approval, could boost the success rate of oncologics in the future, improving the outlook for cancer sufferers and healthcare providers alike.