Lack of evidence that cancer drugs approved by the EMA improve survival

BMJ published a study investigating the effectiveness of 48 drugs approved by the European Medicines Agency.

Cancer drugs in preparation for chemotherapy

Many new drugs for cancer are approved on the basis of surrogate endpoints, which may not accurately predict the treatment’s impact on survival and quality of life.

In a study in the BMJ (4 October 2017), researchers reviewed published data on 48 drugs approved for 68 indications by the European Medicines Agency (EMA) from 2009 to 2013[1]

They found that at the time of approval, 24 (35%) indications had evidence of prolonged survival and 7 (10%) improved quality of life compared with existing treatment options or placebo. In the post-marketing period, there was evidence of prolonged survival for an additional 3 (7%) indications and improved quality of life for 5 (11%) indications. Over a median of 5.4 years’ follow-up, only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain.

The researchers said the findings indicated that it is extremely rare for evidence to confirm that new cancer drugs impact positively upon survival and quality of life following their approval.


[1] Davis C, Naci H, Gurpinar E et al. 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 2009–2013. BMJ 2017;359:j4530. doi: 10.1136/bmj.j4530

Last updated
Clinical Pharmacist, CP, January 2018, Vol 10, No 1;10(1):DOI:10.1211/PJ.2017.20203968

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