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• W2127625089 abstract "The lack of significant gains in the therapy of pancreatic cancer is at least partly attributable to its genetic heterogeneity. Even the current knowledge of these genetic variations opens several possible avenues for biomarkerdriven targeted therapy trials. These trials require the existence or co-development of biomarkers, innovation in design, implementation and regulatory guidance.Recently, the Washington D.C. based ‘think-tank’, the Brookings Institution sponsored a workshop on clinical cancer research (69). This workshop included senior clinical investigators, scientists and representation from pharmaceutical companies and regulatory agencies. The challenges of targeted cancer approval process were recognized and the panel emphasized the need for a pathway for development and early approval of targeted therapies in a narrowly defined population, which would be expanded as subsequent studies merit. The panel’s recommendations included principles for more efficient development of targeted cancer therapies with companion diagnostic tests. If trial results indicated that the therapy was safe and effective in the sub-population identified by an analytically valid diagnostic test, one way to accelerate availability of a promising candidate while further research is conducted would be to grant a “targeted approval” of the diagnostic (for the identification of the patient subgroup studied in the trial) and drug (for use in the subpopulation identified by the test). Full approval of the strategy would be granted upon completion of confirmatory Phase III trials and post-marketing studies.Such a strategy, if implemented, is likely to accelerate the development of targeted therapies for subpopulations of pancreatic cancer." @default.
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• W2127625089 date "2010-09-01" @default.
• W2127625089 modified "2023-09-27" @default.
• W2127625089 title "Personalized therapy for pancreatic cancer: Myth or reality in 2010?" @default.
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• W2127625089 doi "https://doi.org/10.3978/j.issn.2078-6891.2010.009" @default.
• W2127625089 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/3397566" @default.
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