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Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities
Author(s) -
Barone Amy,
Casey Denise,
McKee Amy E.,
Reaman Gregory
Publication year - 2019
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.27809
Subject(s) - medicine , food and drug administration , drug approval , legislation , cancer drugs , legislature , drug , off label use , family medicine , approved drug , alternative medicine , pediatric cancer , cancer , intensive care medicine , pharmacology , pathology , archaeology , political science , law , history
It is well appreciated that the number of anticancer drugs approved for use in children is a fraction of the number approved for use in cancers that occur in adults. We address this fact by summarizing the relevant U.S. legislation that provides the framework for the evaluation and approval of drugs used to treat children with cancer. In total, the Food and Drug Administration (FDA) has approved 38 new drug applications for pediatric oncology indications, 12 of which were new molecular entities. FDA continues to collaborate with multistakeholders regarding the development of products intended for pediatric cancer and encourages the submission of marketing applications.