Open AccessPonatinib: Accelerated Disapproval
Author(s) -
Gainor Justin F.,
Chabner Bruce A.
Publication year - 2015
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2015-0253
Subject(s) - medicine , ponatinib , drug approval , intensive care medicine , toxicity , oncology , drug , family medicine , pharmacology , receptor , dasatinib , tyrosine kinase
“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.