Accelerated approval and oncology drug development timelines

Journal of Clinical Oncology

Volumn 28, Issue 14, 2010, Pages

  Lanthier, Michael L ^a   Sridhara, Rajeshwari ^a   Johnson, John R ^a   Farrell, Ann ^a   Keegan, Patricia ^a   Justice, Robert ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BICALUTAMIDE; CETUXIMAB; DASATINIB; GEFITINIB; ORPHAN DRUG; SUNITINIB; TOSITUMOMAB;

DRUG APPROVAL; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; LETTER; ONCOLOGY; PRIORITY JOURNAL; TIME; UNITED STATES; ANIMAL; BIOASSAY; CLINICAL TRIAL; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; NOTE; TREATMENT OUTCOME;

ANIMALS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; ENDPOINT DETERMINATION; GOVERNMENT REGULATION; HUMANS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77952475409     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.26.2121     Document Type: Letter

References (6)

1. Richey EA, Lyons A, Nebeker JR, et al: Accelerated approval of cancer drugs: Improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs. J Clin Oncol 27:4398-4405, 2009
2. US Food and Drug Administration: FDA Approved Drug Products Database. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
3. US Food and Drug Administration: FDA Approved Drug Products Database: Accelerated Approvals Under Subpart H (drugs) and Subpart E (biologics). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ucm121597.htm
4. Orphan Drug Product Designation Database. http://www.accessdata.fda.gov/ scripts/opdlisting/oopd/index.cfm
5. Sridhara R, Johnson JR, Justice R, et al: Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst doi:10.1093/jnci/djp515 [epub ahead of print on January 29, 2010]
6. Johnson JR, Williams G, Pazdur R: End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21:1404-1411, 2003 (Pubitemid 46606423)