Most Cancer Drugs Approved in Europe Show No Survival Benefit
Even in the postmarketing period, half of cancers have no evidence of significant survival gain
FRIDAY, Oct. 6, 2017 (HealthDay News) -- Most cancer drugs that enter the market in Europe have no evidence of benefit for survival or quality of life, according to a study published online Oct. 4 in BMJ.
Courtney Davis, Ph.D., from King's College London, and colleagues retrospectively reviewed publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013 to determine the availability of data on overall survival and quality-of-life benefits of cancer drugs approved in Europe.
The researchers found that over the study period, the EMA approved the use of 48 cancer drugs for 68 indications. Eight of these indications were approved on the basis of a single-arm study. There was significant prolongation of survival in 24 of the 68 indications (35 percent) at the time of market approval. However, the magnitude of the benefit on overall survival ranged from one to 5.8 months (median, 2.7 months). For the 44 indications for which there was no evidence of a survival gain at the time of market authorization, three indications showed evidence for extension of life and five for benefit in quality of life during the subsequent postmarketing period. After a median of 5.4 years' follow-up, only 35 of the 68 indications demonstrated a significant improvement in survival or quality of life, while 33 remained uncertain.
"At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. While there were survival gains over existing treatment options or placebo, they were often marginal," conclude the authors.