Affiliation:
1. Massachusetts General Hospital, Boston, Massachusetts, USA
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.
Publisher
Oxford University Press (OUP)
Cited by
53 articles.
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