Abstract
“Accelerated Approval” (AA) has addressed important unmet needs in oncology. However, it is only justified if the drug fills a serious gap because such approval entails risk and leads to marketing based on incomplete information about toxicity, dose, and therapeutic potential. Furthermore, the policy of requiring companion diagnostics for AA of drugs that target specific mutations needs further discussion.
MeSH terms
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / pharmacology
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Antineoplastic Agents / therapeutic use*
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Drug Discovery / methods*
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Humans
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Imidazoles / administration & dosage
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Imidazoles / pharmacology
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Imidazoles / therapeutic use*
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Pyridazines / administration & dosage
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Pyridazines / pharmacology
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Pyridazines / therapeutic use*
Substances
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Antineoplastic Agents
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Imidazoles
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Pyridazines
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ponatinib