Velcade®: U.S. FDA Approval for the Treatment of Multiple Myeloma Progressing on Prior Therapy

Oncologist

Volumn 8, Issue 6, 2003, Pages 508-513

  Kane, Robert C ^a   Bross, Peter F ^a   Farrell, Ann T ^a   Pazdur, Richard ^a  

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

Author keywords

Accelerated approval; Bortezomib; Multiple myeloma; Velcade

Indexed keywords

ANTINEOPLASTIC AGENT; BORTEZOMIB; UNCLASSIFIED DRUG; BORONIC ACID DERIVATIVE; PYRAZINE DERIVATIVE;

AGE DISTRIBUTION; ANEMIA; APPETITE DISORDER; ARTHRALGIA; ASTHENIA; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DYSPNEA; EDEMA; EVALUATION; FEVER; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; HYPOKALEMIA; HYPONATREMIA; INSOMNIA; LIVER TOXICITY; MALAISE; MULTIPLE MYELOMA; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; PAIN; PARESTHESIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RACE; RANDOMIZED CONTROLLED TRIAL; RASH; REVIEW; SEX RATIO; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT OUTCOME; UNITED STATES; VERTIGO; VOMITING; DRUG APPROVAL; PATHOLOGY;

ANTINEOPLASTIC AGENTS; BORONIC ACIDS; DRUG APPROVAL; HUMANS; MULTIPLE MYELOMA; PYRAZINES; RANDOMIZED CONTROLLED TRIALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0345447210     PISSN: 10837159     EISSN: None     Source Type: Journal    
DOI: 10.1634/theoncologist.8-6-508     Document Type: Review

References (21)

1. 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;1:453-461.
2. 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;102:1115-1123.
3. Durie BG. Is magnitude of initial response predictive for survival in multiple myeloma? Ann Oncol 1991;2:166-169.
4. Samson D, Gaminara E, Newland A et al. Infusion of vincristine and doxorubicin with oral dexamethasone as first-line therapy for multiple myeloma. Lancet 1989;2:882-885.
5. Palmer M, Belch A, Hanson J et al. Reassessment of the relationship between M-protein decrement and survival in multiple myeloma. Br J Cancer 1989;59:110-112.
6. Durie BG, Russell DH, Salmon SE. Reappraisal of plateau phase in multiple myeloma. Lancet 1980;2:65-68.
7. 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;109:438-446.
8. Gerard CJ, Olsson K, Ramanathan R et al. Improved quantitation of minimal residual disease in multiple myeloma using real-time polymerase chain reaction and plasmid-DNA complementarity determining region III standards. Cancer Res 1998;58:3957-3964.
9. Alexanian R, Bonnet J, Gehan E et al. Combination chemotherapy for multiple myeloma. Cancer 1972;30:382-389.
10. Anderson JR, Cain KC, Gelber RD. Analysis of survival by tumor response. J Clin Oncol 1983;1:710-719.
11. Simon R, Makuch RW. A non-parametric graphical representation of the relationship between survival and the occurrence of an event: application to responder versus non-responder bias. Stat Med 1984;3:35-44.
12. Attal M, Harousseau JL, Stoppa AM et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francaise du Myelome. N Engl J Med 1996;335:91-97.
13. Levy V, Katsahian S, Fermand JP et al. High dose therapy followed by autologous stem cell transplantation or conventional chemotherapy as a first line treatment in multiple myeloma: a meta-analysis on individual patient data of randomized clinical trials with long-term follow-up [abstract]. Blood 2002;100:1556a.
14. Papandreou C, Pagliaro C, Millikan R et al. Phase I study of PS-431, a novel proteasome inhibitor, in patients with advanced malignancies [abstract]. Proc Am Soc Clin Oncol 2000;19:738a.
15. Aghajanian C, Soignet S, Dizon DS et al. A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res 2002;8:2505-2511.
16. Orlowski RZ, Stinchcombe TE, Mitchell BS et al. Phase I trial of the proteasome inhibitor PS-341 in patients with refractory hematologic malignancies. J Clin Oncol 2002;20:4420-4427.
17. Jagannath S, Barlogie B, Berenson J et al. A phase II multicenter randomized study of the proteasome inhibitor bortezomib (VELCADE™, formerly PS-341) in multiple myeloma patients relapsed after front-line therapy [abstract]. Blood 2002;100:3027a.
18. Richardson PG, Barlogie B, Berenson J et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 2003;348:2609-2617.
19. Velcade® label [U.S. package insert]. Available online at http://www.fda.gov/cder/approval/index.htm
20. 21CFR314.510. Available online at http://www.fda.gov/cder/ guidance/append4.pdf
21. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 2003;21:1404-1411.