Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. foodand drugadministrationdrug approval summary

Clinical Cancer Research

Volumn 19, Issue 22, 2013, Pages 6067-6073

  Ning, Yangmin M ^a   Pierce, William ^a   Maher, V Ellen ^a   Karuri, Stella ^a   Tang, Sheng Hui ^a   Chiu, Haw Jyh ^a   Palmby, Todd ^a   Zirkelbach, Jeanne Fourie ^a   Marathe, Dhananjay ^a   Mehrotra, Nitin ^a   Liu, Qi ^a   Ghosh, Debasis ^a   Cottrell, Christy L ^a   Leighton, John ^a   Sridhara, Rajeshwari ^a   Ibrahim, Amna ^a   Justice, Robert ^a   Pazdur, Richard ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; ENZALUTAMIDE; PLACEBO; PROSTATE SPECIFIC ANTIGEN;

ADULT; AGED; AMNESIA; ANDROGEN DEPRIVATION THERAPY; ARTHRALGIA; ARTICLE; ASTHENIA; ATTENTION DISTURBANCE; BACKACHE; BONE METASTASIS; BRONCHITIS; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CAUDA EQUINA SYNDROME; COGNITIVE DEFECT; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; GASTROINTESTINAL DISEASE; HEADACHE; HOT FLUSH; HUMAN; HYPERTENSION; HYPESTHESIA; INFECTION; INFESTATION; LARYNGITIS; LIVER METASTASIS; LOWER RESPIRATORY TRACT INFECTION; LUNG INFECTION; LUNG METASTASIS; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MENTAL DISEASE; METASTASIS POTENTIAL; MUSCLE WEAKNESS; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL STIFFNESS; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PARESTHESIA; PERIPHERAL EDEMA; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; RHINITIS; RHINOPHARYNGITIS; SINUSITIS; SPINAL CORD COMPRESSION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION;

ADULT; AGED; AGED, 80 AND OVER; DRUG APPROVAL; HUMANS; MALE; MIDDLE AGED; PHENYLTHIOHYDANTOIN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; SURVIVAL; TAXOIDS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84888120682     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-1763     Document Type: Article

References (14)

1. Dagher R, Li N, Abraham S, Rahman A, Sridhara R, Pazdur R. Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer. Clin Cancer Res 2004;10:8147-51. (Pubitemid 40053372)
2. Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-12. (Pubitemid 39315317)
3. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010;376:1147-54.
4. Cabazitaxel FDA Medical Review; 2010. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2010/201023s000MedR.pdf.
5. Abiraterone Acetate FDA Medical Review; 2011. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2011/202379Orig1s000MedR.pdf.
6. Attard G, Reid AH, Yap TA, Raynaud F, Dowsett M, Settatree S, et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol 2008;26:4563-71.
7. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005.
8. Chen Y, Clegg NJ, Scher HI. Anti-androgens and androgen-depleting therapies in prostate cancer: new agents for an established target. Lancet Oncol 2009;10:981-91.
9. Tran C, Ouk S, Clegg NJ, Chen Y, Watson PA, Arora V, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009;324:787-90.
10. Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet 2010;375:1437-46.
11. Medivation, Inc. A multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral MDV3100 in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. ClinicalTrials.gov Identifier: NCT00974311; first received on September 9, 2009. Available from: http://www.clinicaltrials.gov/ ct2/show/NCT00974311? term=NCT00974311&rank=1.
12. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367:1187-97.
13. Enzalutamide FDA Multidisciplinary Reviews; 2012. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2012/203415-xtandi-toc.cfm.
14. Medivation, Inc. A multinational Phase 3, randomized, doubleblind, placebo-controlled efficacy and safety study of oral MDV3100 in chemotherapy-naive patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy. ClinicalTrials.gov Identifier: NCT01212991; first received on September 29, 2010. Available from: http://www.clinicaltrials. gov/ct2/show/NCT01212991?term=NCT01212991&rank=1.