Search results for "Accelerated approval"

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Looking for a new panacea in ALK-rearranged NSCLC: may be Ceritinib?

2014

Abstract: In the past decade, the advent of targeted therapy led to a silent revolution in the war against lung cancer and a significant evolution on the concept of Phase I clinical trials design. Thanks to the specificity of their target, the new drugs have radically changed NSCLC treatment, leading to the development of personalized strategies. The accelerated approval of the first ALK-inhibitor, Crizotinib and more recently Ceritinib, without a Phase III randomized, clinical trial, has been an amazing success story in lung cancer research, marking the beginning of a new decade of targeted drugs development, characterized by modern, biomarker-driven, early clinical trial design and shorte…

Oncologymedicine.medical_specialtyPathologyLung NeoplasmsPyridinesSettore MED/06 - Oncologia Medicamedicine.medical_treatmentClinical BiochemistryEML4-ALKCeritinibNSCLCTargeted therapyPanacea (medicine)CrizotinibCarcinoma Non-Small-Cell LungInternal medicineDrug DiscoveryHumansMedicineAnaplastic Lymphoma KinaseMolecular Targeted TherapySulfonesPrecision MedicineLung cancerDrug ApprovalProtein Kinase InhibitorsGene RearrangementPharmacologyCeritinib; Crizotinib; EML4-ALK; NSCLCClinical Trials Phase I as TopicCrizotinibCeritinibbusiness.industryPharmacology. TherapyClinical study designReceptor Protein-Tyrosine Kinasesmedicine.diseaseCeritinib Crizotinib EML4-ALK NSCLCClinical trialPyrimidinesDrug DesignPyrazolesMolecular MedicineAccelerated approvalbusinessmedicine.drugExpert Opinion on Therapeutic Targets
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