Accelerated approval of cancer drugs: Improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?

Journal of Clinical Oncology

Volumn 27, Issue 26, 2009, Pages 4398-4405

  Richey, Elizabeth A ^a   Lyons, E Alison ^a   Nebeker, Jonathan R ^a   Shankaran, Veena ^a   McKoy, June M ^a   Luu, Thanh Ha ^a   Nonzee, Narissa ^a   Trifilio, Steven ^a   Sartor, Oliver ^a   Benson III, Al B ^a   Carson, Kenneth R ^a   Edwards, Beatrice J ^a   Gilchrist Scott, Douglas ^a   Kuzel, Timothy M ^a   Raisch, Dennis W ^a   Tallman, Martin S ^a   West, Dennis P ^a   Hirschfeld, Steven ^a   Grillo Lopez, Antonio J ^a   Bennett, Charles L ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; ALITRETINOIN; ANTINEOPLASTIC AGENT; BEXAROTENE; CAPECITABINE; CETUXIMAB; CLOFARABINE; DENILEUKIN DIFTITOX; DOCETAXEL; EPIRUBICIN; EXEMESTANE; GEFITINIB; GEMTUZUMAB OZOGAMICIN; IBRITUMOMAB TIUXETAN; IMATINIB; IRINOTECAN; NELARABINE; NEW DRUG; NILOTINIB; ORPHAN DRUG; OXALIPLATIN; PANITUMUMAB; PHOTOFRIN; RITUXIMAB; SUNITINIB; TEMOZOLOMIDE; TOREMIFENE; TOSITUMOMAB; UNINDEXED DRUG; VALRUBICIN;

ARTICLE; BLADDER CANCER; BREAST CANCER; CLINICAL STUDY; COLORECTAL CANCER; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG INDICATION; DRUG LABELING; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TREATMENT FAILURE; ESOPHAGUS CANCER; FOOD AND DRUG ADMINISTRATION; KIDNEY CANCER; MESOTHELIOMA; PRIORITY JOURNAL; PROSTATE CANCER; UTERINE CERVIX CANCER; DRUG MANUFACTURE; HUMAN; KAPLAN MEIER METHOD; LEGAL ASPECT; METHODOLOGY; NEOPLASM; PHASE 3 CLINICAL TRIAL; PROPORTIONAL HAZARDS MODEL; STATISTICS; TIME; UNITED STATES;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG APPROVAL; HUMANS; KAPLAN-MEIERS ESTIMATE; NEOPLASMS; ORPHAN DRUG PRODUCTION; PROPORTIONAL HAZARDS MODELS; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70349315347     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.21.1961     Document Type: Article

References (18)

1. Clinton W, Gore A: Reinventing the regulation of cancer drugs: National performance review, 1996. http://www.fda.gov/ohrms/dockets/ac/05/briefing/ 2005-4191B1-01-03-Reinvent-Cancer-Drugs.pdf
2. US Food and Drug Administration: 21 Code of Federal Regulations, Part 314.510. Silver Spring, MD, US Food and Drug Administration, 2008
3. Roberts TG Jr, Chabner BA: Beyond fast track for drug approvals. N Engl J Med 351:501-505, 2004
4. Oncologic Drugs Advisory Committee Meeting Transcript for March 12, 2003. In: Department of Health and Human Services; Food and Drug Administration Center for Drug Evaluation and Research; 2005
5. Dagher R, Johnson J, Williams G, et al: Accelerated approval of oncology products: A decade of experience. J Natl Cancer Inst 96:1500-1509, 2004
6. US Food and Drug Administration, Center for Drug Evaluation and Research: Oncologic Drugs Advisory Committee Meeting Transcript for November 8, 2005. Washington, DC, Department of Health and Human Services, 2005
7. Finkelstein JB: Accelerated approval regulations may need overhaul, panel suggests. J Natl Cancer Inst 97:1802-1804, 2005
8. Schilsky RL: Hurry up and wait: Is accelerated approval of new cancer drugs in the best interests of cancer patients? J Clin Oncol 21:3718-3720, 2003
9. US Senate, 110th Congress: Food and Drug Administration Revitalization Act, 2007
10. Bennett C, Carson K, Shankaran V, Richey E: Is the accelerated FDA approval pathway decelerating? Oncology News International 17:12-13, 2008
11. Stahl J: History of accelerated approval: Overcoming the FDA's bureaucratic barriers in order to expedite desperately needed drugs to critically ill patients [third-year paper]. Harvard Law School, Cambridge, MA, 2005
12. US Senate, 101st Congress: S 3046, 2008. http://www.govtrack.us/congress/ billtext.xpd?bill= s110-1082
13. National Cancer Institute. National Cancer Institute clinical trials. http://www.nci.nih.gov/clinicaltrials
14. US Food and Drug Administration: Center for Drug Evaluation and Research. Drugs@FDA: FDA approved drug products. http://www.accessdata.fda .gov/Scripts/cder/DrugsatFDA/
15. US Food and Drug Administration. List of orphan designations and approvals.http://www.fda .gov/orphan/designat/list.htm
16. US Food and Drug Administration. Definition of disease prevalence for therapies qualifying under the orphan drug act. http://www.fda.gov/orphan/ designat/prevalence.html+
17. Piana R: Cancer drug pipeline is healthy, says head of oncologic drug approval for FDA. Oncology News International 17:24, 2008
18. Ladewski LA, Belknap SM, Nebeker JR, et al: Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project. J Clin Oncol 21: 3859-3866, 2003