Matches in SemOpenAlex for { <https://semopenalex.org/work/W2761792472> ?p ?o ?g. }
- W2761792472 endingPage "j4530" @default.
- W2761792472 startingPage "j4530" @default.
- W2761792472 abstract "<b>Objective</b> To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. <b>Design</b> Retrospective cohort study. <b>Setting</b> Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. <b>Main outcome measures</b> Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. <b>Results</b> From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). <b>Conclusions</b> This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. 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. When there were survival gains over existing treatment options or placebo, they were often marginal." @default.
- W2761792472 created "2017-10-20" @default.
- W2761792472 creator A5017538000 @default.
- W2761792472 creator A5033287152 @default.
- W2761792472 creator A5046080513 @default.
- W2761792472 creator A5056116418 @default.
- W2761792472 creator A5058432825 @default.
- W2761792472 creator A5074047848 @default.
- W2761792472 date "2017-10-04" @default.
- W2761792472 modified "2023-10-09" @default.
- W2761792472 title "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 2009-13" @default.
- W2761792472 cites W1513425378 @default.
- W2761792472 cites W1570249624 @default.
- W2761792472 cites W1810662963 @default.
- W2761792472 cites W1882099583 @default.
- W2761792472 cites W1969164468 @default.
- W2761792472 cites W1989308735 @default.
- W2761792472 cites W1996778928 @default.
- W2761792472 cites W2001096163 @default.
- W2761792472 cites W2003422786 @default.
- W2761792472 cites W2021158896 @default.
- W2761792472 cites W2037624670 @default.
- W2761792472 cites W2043962455 @default.
- W2761792472 cites W2050249255 @default.
- W2761792472 cites W2055346449 @default.
- W2761792472 cites W2062448901 @default.
- W2761792472 cites W2082122438 @default.
- W2761792472 cites W2084919734 @default.
- W2761792472 cites W2092238717 @default.
- W2761792472 cites W2097995306 @default.
- W2761792472 cites W2098775844 @default.
- W2761792472 cites W2100439220 @default.
- W2761792472 cites W2100912832 @default.
- W2761792472 cites W2101021708 @default.
- W2761792472 cites W2102116016 @default.
- W2761792472 cites W2102306754 @default.
- W2761792472 cites W2103405666 @default.
- W2761792472 cites W2103563357 @default.
- W2761792472 cites W2110547498 @default.
- W2761792472 cites W2110882721 @default.
- W2761792472 cites W2111404068 @default.
- W2761792472 cites W2112621029 @default.
- W2761792472 cites W2113057788 @default.
- W2761792472 cites W2115658806 @default.
- W2761792472 cites W2115731038 @default.
- W2761792472 cites W2115735904 @default.
- W2761792472 cites W2115837083 @default.
- W2761792472 cites W2116536708 @default.
- W2761792472 cites W2116949558 @default.
- W2761792472 cites W2122566405 @default.
- W2761792472 cites W2123363005 @default.
- W2761792472 cites W2123526148 @default.
- W2761792472 cites W2126251787 @default.
- W2761792472 cites W2126275851 @default.
- W2761792472 cites W2127152525 @default.
- W2761792472 cites W2134119471 @default.
- W2761792472 cites W2134189551 @default.
- W2761792472 cites W2135630936 @default.
- W2761792472 cites W2135906122 @default.
- W2761792472 cites W2137228442 @default.
- W2761792472 cites W2147834058 @default.
- W2761792472 cites W2148643283 @default.
- W2761792472 cites W2151082560 @default.
- W2761792472 cites W2151262170 @default.
- W2761792472 cites W2151333691 @default.
- W2761792472 cites W2151337547 @default.
- W2761792472 cites W2159179344 @default.
- W2761792472 cites W2159967578 @default.
- W2761792472 cites W2165335733 @default.
- W2761792472 cites W2165771694 @default.
- W2761792472 cites W2167191456 @default.
- W2761792472 cites W2167224460 @default.
- W2761792472 cites W2167341150 @default.
- W2761792472 cites W2168108459 @default.
- W2761792472 cites W2170241131 @default.
- W2761792472 cites W2212551923 @default.
- W2761792472 cites W2295991491 @default.
- W2761792472 cites W2343707441 @default.
- W2761792472 cites W2464447852 @default.
- W2761792472 cites W2530600980 @default.
- W2761792472 cites W2557938525 @default.
- W2761792472 cites W2558674288 @default.
- W2761792472 cites W2559973713 @default.
- W2761792472 cites W2589693917 @default.
- W2761792472 cites W2609272592 @default.
- W2761792472 cites W2610868846 @default.
- W2761792472 cites W2623751563 @default.
- W2761792472 cites W2735286383 @default.
- W2761792472 cites W2735933656 @default.
- W2761792472 cites W2746717271 @default.
- W2761792472 doi "https://doi.org/10.1136/bmj.j4530" @default.
- W2761792472 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/5627352" @default.
- W2761792472 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/28978555" @default.
- W2761792472 hasPublicationYear "2017" @default.
- W2761792472 type Work @default.
- W2761792472 sameAs 2761792472 @default.
- W2761792472 citedByCount "406" @default.
- W2761792472 countsByYear W27617924722017 @default.