U.S. Food and Drug Administration approval: Carfilzomib for the treatment of multiple myeloma

Clinical Cancer Research

Volumn 19, Issue 17, 2013, Pages 4559-4563

  Herndon, Thomas M ^a   Deisseroth, Albert ^a   Kaminskas, Edvardas ^a   Kane, Robert C ^a   Koti, Kallappa M ^a   Rothmann, Mark D ^a   Habtemariam, Bahru ^a   Bullock, Julie ^a   Bray, Jeffrey D ^a   Hawes, Jessica ^a   Palmby, Todd R ^a   Jee, Josephine ^a   Adams, William ^a   Mahayni, Houda ^a   Brown, Janice ^a   Dorantes, Angelica ^a   Sridhara, Rajeshwari ^a   Farrell, Ann T ^a   Pazdur, Richard ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ASPARTATE AMINOTRANSFERASE; BORTEZOMIB; CARFILZOMIB; CREATININE; DEXAMETHASONE; IMMUNOMODULATING AGENT; INFUSION FLUID;

ACUTE KIDNEY FAILURE; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTHRALGIA; ASTHENIA; BACKACHE; CHEMOTHERAPY INDUCED EMESIS; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHILL; CONGESTIVE HEART FAILURE; CONSTIPATION; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE COURSE; DIZZINESS; DRUG APPROVAL; DRUG DEGRADATION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG RESPONSE; DRUG SAFETY; DRUG STRUCTURE; DYSPNEA; FATIGUE; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERCALCEMIA; HYPERGLYCEMIA; HYPERTENSION; HYPESTHESIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; INSOMNIA; KIDNEY DYSFUNCTION; LEUKOPENIA; LIMB PAIN; LYMPHOCYTOPENIA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MUSCLE SPASM; NEUTROPENIA; NONHUMAN; PAIN; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PNEUMONIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PULMONARY HYPERTENSION; REVIEW; SIDE EFFECT; THORAX PAIN; THROMBOCYTOPENIA; TUMOR LYSIS SYNDROME; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION;

ADULT; AGED; AGED, 80 AND OVER; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTIPLE MYELOMA; OLIGOPEPTIDES; PROTEASOME INHIBITORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84883472160     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-0755     Document Type: Review

References (18)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin 2012;62:10-29.
2. Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, et al. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc 2003;78:21-33. (Pubitemid 36033957)
3. Raab MS, Podar K, Breitkreutz I, Richardson PG, Anderson KC. Multiple myeloma. Lancet 2009:374;324-39.
4. Palumbo A, Anderson K. Multiple myeloma. N Engl J Med 2011;364:1046-60.
5. Herschko A, Ciechanover A. The ubiquitin system. Annu Rev Biochem 1998;67:425-79. (Pubitemid 28411135)
6. Hochstrasser M. Ubiquitin-dependent protein degradation. Annu Rev Genet 1996;30:405-39. (Pubitemid 27014474)
7. Baumeister W, Walz J, Zühl F, Seemüller E. The proteasome: paradigm of a self-compartmentalizing protease. Cell 1998;92:367-80. (Pubitemid 28093014)
8. Coux O, Tanaka K, Goldberg AL. Structure and functions of the 20S and 26S proteasomes. Annu Rev Biochem 1996;65:801-47. (Pubitemid 26255262)
9. Hoffman L, Rechsteiner M. Regulatory features of multicatalytic and 26S proteases. Curr Top Cell Regul 1996;34:1-32.
10. Hochstrasser M. Ubiquitin, proteasomes, and the regulation of intracellular protein degradation. Curr Opin Cell Biol 1995;7:215-23.
11. Kuhn DJ, Chen Q, Voorhees PM, Strader JS, Shenk KD, Sun CM, et al. Potent activity of carfilzomib, a novel, irreversible inhibitor of the ubiquitin-proteasome pathway, against preclinical models of multiple myeloma. Blood 2007;110:3281-90. (Pubitemid 350106321)
12. Badros AZ, Vij R, Martin T, Zonder JA, Kunkel L, Wang Z, et al. Carfilzomib in multiple myeloma patients with renal impairment: pharmacokinetics and safety. Leukemia 2013 Jan 31. [Epub ahead of print].
13. Durie BGM, Harousseau JL, Miguel JS, Bladé J, Barlogie B, Anderson K, et al. International uniform response criteria for multiple myeloma. Leukemia 2006;20:1467-73. (Pubitemid 44264086)
14. http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ ctcaev3.pdf.
15. Bross PF, Kane R, Farrell AT, Abraham S, Benson K, Bradley S, et al. Approval summary for bortezomib for Injection in the treatment of multiple myeloma. Clin Cancer Res 2004;10:3954-64. (Pubitemid 38812468)
16. Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 2005;352:2487-98 (Pubitemid 41007864)
17. Kane RC, Farrell AT, Sridhara R, Pazdur R. United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy. Clin Cancer Res 2006;12:2955-60. (Pubitemid 43837337)
18. San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med 2008:359;906-17.