Approval summary for bortezomib for injection in the treatment of multiple myeloma

Clinical Cancer Research

Volumn 10, Issue 12 I, 2004, Pages 3954-3964

  Bross, Peter F ^a   Kane, Robert ^a   Farrell, Ann T ^a   Abraham, Sophia ^a   Benson, Kimberly ^a   Brower, Margaret E ^a   Bradley, Sean ^a   Gobburu, Jogarao V ^a   Goheer, Anwar ^a   Lee, Shwu Luan ^a   Leighton, John ^a   Liang, Cheng Yi ^a   Lostritto, Richard T ^a   McGuinn, William D ^a   Morse, David E ^a   Rahman, Atiqur ^a   Rosario, Lilliam A ^a   Verbois, S Leigh ^a   Williams, Grant ^a   Wang, Yong Cheng ^a   Pazdur, Richard ^a   more..

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

Author keywords

[No Author keywords available]

Indexed keywords

BORONIC ACID DERIVATIVE; BORTEZOMIB;

ANEMIA; ANOREXIA; APPETITE DISORDER; ARTHRALGIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CARDIOTOXICITY; CHEMICAL ANALYSIS; CLINICAL TRIAL; CONSTIPATION; DEMYELINATION; DIARRHEA; DOSE CALCULATION; DRUG APPROVAL; DRUG EFFICACY; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; FATIGUE; FEVER; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TOXICITY; HEADACHE; HISTOPATHOLOGY; HUMAN; IMMOBILIZATION; INSOMNIA; LEG PAIN; MALAISE; MONKEY; MONOTHERAPY; MULTIPLE MYELOMA; MUSCLE WEAKNESS; NAUSEA; NERVE FIBER DEGENERATION; NEUROTOXICITY; NEUTROPENIA; NONHUMAN; PERIPHERAL NERVE; PERIPHERAL NEUROPATHY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RAT; REDUCED PHYSICAL ACTIVITY; SENSORY NEUROPATHY; SPINAL CORD; SPINAL GANGLION; THROMBOCYTOPENIA; TOXICOKINETICS; TOXICOLOGY; TREMOR; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BORONIC ACIDS; CLINICAL TRIALS; DRUG APPROVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; MODELS, CHEMICAL; MULTIPLE MYELOMA; PROTEASOME ENDOPEPTIDASE COMPLEX; PYRAZINES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 3042577683     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-03-0781     Document Type: Article

References (51)

1. Riedel DA, Pottern LM. The epidemiology of multiple myeloma. Hematol Oncol Clin North Am 1992;6:225-47.
2. Bergsagel DE, Sprague CC, Austin C. Evaluation of new chemotherapeutic agents in the treatment of multiple myeloma. IV. L-phenalalenine mustard (NSC8806). Cancer Chemother Rep 1962;21:87-99.
3. Alexanian R, Dimopoulos M. The treatment of multiple myeloma. N Engl J Med 1994;330:484-9.
4. Myeloma Trialists' Collaborative Group. Combination chemotherapy versus melphalan plus prednisone as treatment for MM: an overview of 6,633 patients from 27 randomized trials. J Clin Oncol 1998;16:3832-42.
5. Vesole DH, Barlogie B, Jagannath S, et al. High-dose therapy for refractory multiple myeloma: improved prognosis with better supportive care and double transplants. Blood 1994;84:950-6.
6. Attal M, Harousseau JL, Facon T, et al. InterGroupe Francophone du Myelome. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 2003;349:2495-502.
7. Segeren CM, Sonneveld P, van der Holt B, et al. Dutch-Belgian Hemato-Oncology Cooperative Study Group. Overall and event-free survival are not improved by the use of myeloablative therapy following intensified chemotherapy in previously untreated patients with multiple myeloma: a prospective randomized phase 3 study. Blood 2003;101:2144-51.
8. Child JA, Morgan GJ, Davies FE, et al. Medical Research Council Adult Leukemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 2003;348:1875-83.
9. Kumar S, Larson D, Therneau T, Kyle R, Greipp P. Natural history of relapsed multiple myeloma [abstract]. Blood Proc Am Soc Hematol 2002;100:598a.
10. Salmon SC, Shadduck RK, Shilling A. Intermittent high dose prednisone therapy for multiple myeloma. Cancer Chemother Rep 1967;51:179-87.
11. Singhal S, Mehta J, Desikan R, et al. Antitumor activity of thalidomide in refractory multiple myeloma N Engl J Med 1999;341:1565-71.
12. Rajkumar SV, Gertz MA, Lacy MQ, et al. Thalidomide as initial therapy for early-stage myeloma. Leukemia (Baltimore) 2003;17:775-9.
13. Kumar S, Gertz MA, Dispenzieri A, et al. Response rate, durability of response, and survival after thalidomide therapy for relapsed multiple myeloma. Mayo Clin Proc 2003;78:34-9.
14. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 2003;348:2609-17.
15. Chronic Leukemia and Myeloma Task Force of the National Cancer Institute. Proposed guidelines for protocol studies. II. Plasma cell myeloma. Cancer Chemother Rep 1973;4:145-58.
16. Alexanian R, Bonnet J, Gehan E. Combination chemotherapy for multiple myeloma. Cancer (Phila) 1972;30:382-9.
17. Salmon SE, Haut A, Bonnet JD, et al. Alternating combination chemotherapy and levamisole improves survival in multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol 1983;1:453-61.
18. Gore ME, Selby PJ, Viner C, et al. Intensive treatment of multiple myeloma and criteria for complete remission. Lancet 1989;2:879-82.
19. Harousseau JL, Attal M, Divine M, et al. Autologous stem cell transplantation after first remission induction treatment in multiple myeloma: a report of the French Registry on autologous transplantation in multiple myeloma. Blood 1995;85:3077-85.
20. Salmon SE, Crowley JJ, Balcerzak SP, et al. Interferon versus interferon plus prednisone remission maintenance therapy for multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol 1998;16:890-6.
21. Attal M, Harousseau J-L, Stoppa A-M, et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. N Engl J Med 1996;335:91-7.
22. Blade J, Samson D, Reece D, et al. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol 1998;102:1115-23.
23. Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol 2003;21:16-9.
24. Dimopoulos MA, Pouli A, Zervas K, et al. Greek Myeloma Study Group. Prospective randomized comparison of vincristine, doxorubicin and dexamethasone (VAD) administered as intravenous bolus injection and VAD with liposomal doxorubicin as first-line treatment in multiple myeloma. Ann Oncol 2003;14:1039-44.
25. Lahuerta JJ, Martinez-Lopez J, Serna JD, et al. Remission status defined by immunofixation vs. electrophoresis after autologous transplantation has a major impact on the outcome of multiple myeloma patients. Br J Haematol 2000;109:438-46.
26. Pickart CM. Mechanisms underlying ubiquitination. Annu Rev Biochem 2001;70:503-33.
27. Zwickl P, Grziwa A, Puhler G, Dahlmann B, Lottspeich F, Baumeister W. Primary structure of the Thermoplasma proteasome and its implications for the structure, function, and evolution of the multicatalytic proteinase. Biochemistry 1992;31:964-72.
28. W Baumeister Walz J, Zuhl F, Seemuller E. The proteasome: paradigm of a self-compartmentalizing protease. Cell 1998;92:367-80.
29. Lowe J, Stock D, Jap B, Zwickl P, Baumeister W, Huber R. Crystal structure of the 20S proteasome from the archaeon T. acidophilum at 3.4 A resolution. Science (Wash DC) 1995;268:533-9.
30. Adams GM, Falke S, Goldberg AL, Slaughter CA, DeMartino GN, Gogol EP. Structural and functional effects of PA700 and modulator protein on proteasomes. J Mol Biol 1997;273:646-57.
31. Adams GM, Crotchett B, Slaughter CA, DeMartino GN, Gogol EP. Formation of proteasome-PA700 complexes directly correlates with activation of peptidase activity. Biochemistry 1998;37:12927-32.
32. Gray CW, Slaughter CA, DeMartino GN. PA28 activator protein forms regulatory caps on proteasome stacked rings. J Mol Biol 1994;236:7-15.
33. Groll M, Huber R. Substrate access and processing by the 20S proteasome core particle. Int J Biochem Cell Biol 2003;35:606-16.
34. Beg AA, Baltimore D. An essential role for NF-κB in preventing TNF- α-induced cell death. Science (Wash DC) 1996;274:782-4.
35. Van Antwerp DJ, Martin SJ, Kafri T, Green DR, Verma IM. Suppression of TNF- α-induced apoptosis by NF-κB. Science (Wash DC) 1996;274:787-9.
36. Van Antwerp DJ, Verma IM. Signal induced degradation of IκBα: association with NF-κB and the PEST sequence in IκBα are not required. Mol Cell Biol 1996;16:6037-45.
37. Schwarz EM, Van Antwerp D, Verma IM. Constitutive phosphorylation of IκBα by casein kinase II occurs preferentially at serine 293: requirement for degradation of free IκBα. Mol Cell Biol 1996;16:3554-9.
38. Adams J, Palombella VJ, Sausville EA, et al. Proteasome inhibitors: a novel class of potent and effective antitumor agents. Cancer Res 1999;59:2615-22.
39. Ma J, Wollmann R, Lindquist S. Neurotoxicity and neurodegeneration when PrP accumulates in the cytosol. Science (Wash DC) 2002;298:1781-5.
40. Adams J. Development of the proteasome inhibitor PS-341. Oncologist 2002;7:9-16.
41. 2-M-phase arrest and apoptosis in human non-small cell lung cancer cell lines. Clin Cancer Res 2003;9:1145-54.
42. Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ. Proteasome inhibition measurements: clinical application. Clin Chem 2000;46:673-83.
43. Bardag-Gorce F, Li J, French BA, French SW. Ethanol withdrawal induced CYP2E1 degradion in vivo, blocked by proteasomal inhibitor PS-341. Free Radic Biol Med 2002;32:17-21.
44. Korsmeyer KK, Davoll S, Figueiredo-Pereira ME, Correia MA. Proteolytic degradation of heme-modified hepatic cytochromes P450: A role for phosphorylation, ubiquitination and the 26S proteasome? Arch Biochem Biophys 1999;365:31-44.
45. Correia MA. Hepatic cytochrome P450 degradation: mechanistic diversity of the cellular sanitation brigade. Drug Metab Rev 2003;35:107-43.
46. Jagannath S, Barlogie B, Berenson J, et al. A phase 2 multicenter randomized study of the protease inhibitor bortezomib (VELCADE, formerly PS-341) in multiple myeloma patients relapsed after front line therapy [abstract]. Blood Proc Am Soc Hematol 2002;100:812a.
47. Kropff MH, Lang N, Bisping G, et al. Hyperfractionated cyclophosphamide in combination with pulsed dexamethasone and thalidomide (HyperCDT) in primary refractory or relapsed multiple myeloma. Br J Haematol 2003;122:607-16.
48. Dimopoulos MA, Weber D, Kantarjian H, Delasalle KB, Alexanian R. HyperCVAD for VAD-resistant multiple myeloma. Am J Hematol 1996;52:77-81.
49. Vesole DH, Crowley JJ, Catchatourian R, et al. High-dose melphalan with autotransplantation for refractory multiple myeloma: results of a Southwest Oncology Group Phase II trial. J Clin Oncol 1999;17:2173-9.
50. Pandit S, Vesole DH. Relapsed multiple myeloma. Curr Treat Options Oncol 2001;2:261-9.
51. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 2003;21:1404-11.