Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities.
Pediatr Blood Cancer
; 66(8): e27809, 2019 08.
Article
in En
| MEDLINE
| ID: mdl-31144772
ABSTRACT
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drug Approval
/
Neoplasms
/
Antineoplastic Agents
Limits:
Child
/
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Pediatr Blood Cancer
Year:
2019
Document type:
Article