Changing end points in breast-cancer drug approval - The avastin story

New England Journal of Medicine

Volumn 365, Issue 2, 2011, Pages

  D'Agostino Sr , Ralph B ^a  

^a Boston University   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE DERIVATIVE; BEVACIZUMAB; CAPECITABINE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; PLACEBO; TAXANE DERIVATIVE;

BREAST CANCER; CARDIOVASCULAR DISEASE; DRUG APPROVAL; DRUG EFFICACY; DRUG FATALITY; DRUG INDICATION; DRUG INDUSTRY; DRUG LABELING; DRUG SAFETY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL DECISION MAKING; METASTASIS POTENTIAL; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SHORT SURVEY; TREATMENT OUTCOME;

EID: 79960241809     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/nejmp1106984     Document Type: Article

References (5)

1. Food and Drug Administration Oncologic Drugs Advisory Committee. Transcripts of the December 5, 2007, meeting. (http://www.fda.gov/ohrms/dockets/ ac/cder07.htm# OncologicDrugs.)
2. Panageas KS, Ben-Porat L, Dickler MN, Chapman PB, Schrag D. When you look matters: the effect of assessment schedule on progression-free survival. J Natl Cancer Inst 2007;99:428-32. (Pubitemid 47073565)
3. Sledge GW, Neuberg D, Bernardo P, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003;21:588-92. (Pubitemid 46621890)
4. Muggia FM, Braly PS, Brady MF, et al. Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: a gynecologic oncology group study. J Clin Oncol 2000;18:106-15. (Pubitemid 30036343)
5. Food and Drug Administration Oncologic Drug Advisory Committee. Transcript of the July 20, 2010, meeting. (http://www.fda.gov/downloads/ AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ OncologicDrugsAdvisoryCommittee/UCM221998.pdf.)