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dc.contributor.authorPearson, ADJen_US
dc.contributor.authorPfister, SMen_US
dc.contributor.authorBaruchel, Aen_US
dc.contributor.authorBourquin, J-Pen_US
dc.contributor.authorCasanova, Men_US
dc.contributor.authorChesler, Len_US
dc.contributor.authorDoz, Fen_US
dc.contributor.authorEggert, Aen_US
dc.contributor.authorGeoerger, Ben_US
dc.contributor.authorJones, DTWen_US
dc.contributor.authorKearns, PRen_US
dc.contributor.authorMolenaar, JJen_US
dc.contributor.authorMorland, Ben_US
dc.contributor.authorSchleiermacher, Gen_US
dc.contributor.authorSchulte, JHen_US
dc.contributor.authorVormoor, Jen_US
dc.contributor.authorMarshall, LVen_US
dc.contributor.authorZwaan, CMen_US
dc.contributor.authorVassal, Gen_US
dc.contributor.authorExecutive and Biology Committees of the Innovative Therapies for Children with Cancer European Consortiumen_US
dc.coverage.spatialEnglanden_US
dc.date.accessioned2018-02-16T10:15:49Z
dc.date.issued2017-07en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/28677575en_US
dc.identifierS1470-2045(17)30442-4en_US
dc.identifier.citationLancet Oncol, 2017, 18 (7), pp. e394 - e404en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1176
dc.identifier.eissn1474-5488en_US
dc.identifier.doi10.1016/S1470-2045(17)30442-4en_US
dc.description.abstractNew drugs are crucially needed for children with cancer. The European Paediatric Regulation facilitates paediatric class waivers for drugs developed for diseases only occurring in adults. In this Review, we retrospectively searched oncology drugs that were class waivered between June, 2012, and June, 2015. 147 oncology class waivers were confirmed for 89 drugs. Mechanisms of action were then assessed as potential paediatric therapeutic targets by both a literature search and an expert review. 48 (54%) of the 89 class-waivered drugs had a mechanisms of action warranting paediatric development. Two (2%) class-waivered drugs were considered not relevant and 16 (18%) required further data. In light of these results, we propose five initiatives: an aggregated database of paediatric biological tumour drug targets; molecular profiling of all paediatric tumours at diagnosis and relapse; a joint academic-pharmaceutical industry preclinical platform to help analyse the activity of new drugs (Innovative Therapy for Children with Cancer Paediatric Preclinical Proof-of-Concept Platform); paediatric strategy forums; and the suppression of article 11b of the European Paediatric Regulation, which allows product-specific waivers on the grounds that the associated condition does not occur in children. These initiatives and a mechanism of action-based approach to drug development will accelerate the delivery of new therapeutic drugs for front-line therapy for those children who have unmet medical needs.en_US
dc.format.extente394 - e404en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectAdolescenten_US
dc.subjectAntineoplastic Agentsen_US
dc.subjectBiological Productsen_US
dc.subjectChilden_US
dc.subjectChild, Preschoolen_US
dc.subjectDrug Discoveryen_US
dc.subjectEuropeen_US
dc.subjectHumansen_US
dc.subjectInfanten_US
dc.subjectInfant, Newbornen_US
dc.subjectLegislation, Drugen_US
dc.subjectNeoplasmsen_US
dc.subjectPrecision Medicineen_US
dc.titleFrom class waivers to precision medicine in paediatric oncology.en_US
dc.typeJournal Article
dcterms.dateAccepted2017-05-04en_US
rioxxterms.versionofrecord10.1016/S1470-2045(17)30442-4en_US
rioxxterms.licenseref.startdate2017-07en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfLancet Oncolen_US
pubs.issue7en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics/Paediatric Solid Tumour Biology and Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Paediatric Solid Tumour Biology and Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Paediatric Solid Tumour Biology and Therapeutics
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume18en_US
pubs.embargo.termsNot knownen_US
icr.researchteamPaediatric Solid Tumour Biology and Therapeuticsen_US
dc.contributor.icrauthorChesler, Louisen_US
dc.contributor.icrauthorMarsden,en_US


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