Pomalidomide: First global approval

Drugs

Volumn 73, Issue 6, 2013, Pages 595-604

  Elkinson, Shelley ^a   McCormack, Paul L ^b  

^a Adis R and D Insight   (New Zealand)

^b ADIS   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; CARFILZOMIB; CDC 394; CLARITHROMYCIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; GAMMA INTERFERON; IMID; INTERLEUKIN 2; INTERLEUKIN 6; LENALIDOMIDE; MELPHALAN; PLACEBO; POMALIDOMIDE; PREDNISONE; THALIDOMIDE; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG; VASCULOTROPIN;

AMYLOIDOSIS; ANEMIA; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; AREA UNDER THE CURVE; ARTICLE; CANCER PATIENT; CANCER PROGNOSIS; CANCER RECURRENCE; CYTOKINE PRODUCTION; DIARRHEA; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXCRETION; DRUG FORMULATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EDEMA; FATIGUE; FOOD AND DRUG ADMINISTRATION; GRAFT VERSUS HOST REACTION; HAZARD RATIO; HUMAN; HYPERGLYCEMIA; IMMUNOMODULATION; IN VITRO STUDY; IN VIVO STUDY; LOW DRUG DOSE; LUNG SMALL CELL CANCER; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MYELOFIBROSIS; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PATENT; PERIPHERAL BLOOD MONONUCLEAR CELL; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; RASH; RECOMMENDED DRUG DOSE; SINGLE DRUG DOSE; THROMBOCYTOPENIA; THROMBOSIS; TIME TO MAXIMUM PLASMA CONCENTRATION; WALDENSTROEM MACROGLOBULINEMIA;

ANGIOGENESIS INHIBITORS; ANIMALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; GRAFT VS HOST DISEASE; HUMANS; MULTIPLE MYELOMA; THALIDOMIDE;

EID: 84878271411     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0047-x     Document Type: Article

References (53)

1. SK Kumar SV Rajkumar A Dispenzieri, et al. 2008 Improved survival in multiple myeloma and the impact of novel therapies Blood. 111 2516 2520 17975015 10.1182/blood-2007-10-116129 1:CAS:528:DC%2BD1cXivFaktrk%3D
2. MP Curran K McKeage 2009 Bortezomib: a review of its use in patients with multiple myeloma Drugs. 69 7 859 888 19441872 10.2165/00003495-200969070-00006 1:CAS:528:DC%2BD1MXosVarsbk%3D
3. LJ Scott KA Lyseng-Williamson 2011 Lenalidomide: a review of its use in the treatment of relapsed or refractory multiple myeloma Drugs. 71 5 625 649 21443285 10.2165/11206420-000000000-00000 1:CAS:528:DC%2BC3MXntlamsLg%3D
4. GL Plosker 2008 Pegylated liposomal doxorubicin: a review of its use in the treatment of relapsed or refractory multiple myeloma Drugs. 68 17 2535 2551 19016577 10.2165/0003495-200868170-00008 1:CAS:528:DC%2BD1MXitF2hurg%3D
5. S Singhal J Mehta R Desikan, et al. 1999 Antitumor activity of thalidomide in refractory multiple myeloma N Engl J Med. 341 1565 1571 10564685 10.1056/NEJM199911183412102 1:CAS:528:DyaK1MXotVSgs78%3D
6. F Payvandi L Wu M Haley, et al. 2004 Immunomodulatory drugs inhibit expression of cyclooxygenase-2 from TNF-alpha, IL-1beta, and LPS-stimulated human PBMC in a partially IL-10-dependent manner Cell Immunol. 230 2 81 88 15598423 10.1016/j.cellimm.2004.09.003 1:CAS:528:DC%2BD2cXhtVOntbzK
7. F Payvandi L Wu SD Naziruddin, et al. 2005 Immunomodulatory drugs (IMiDs) increase the production of IL-2 from stimulated T cells by increasing PKC-theta activation and enhancing the DNA-binding activity of AP-1 but not NF-kappaB, OCT-1, or NF-AT J Interferon Cytokine Res. 25 10 604 616 16241859 10.1089/jir.2005.25.604 1:CAS:528:DC%2BD2MXhtFartbnJ
8. US FDA. FDA approves Pomalyst for advanced multiple myeloma [media release]. 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm338895.htm. Accessed 8 Feb 2013.
9. ® (pomalidomide) capsules, for oral use: prescribing information. 2013. http://www.accessdata.fda.gov/drugsatfda-docs/ label/2013/204026lbl.pdf. Accessed 26 Feb 2013.
10. Richardson PG, Siegel DS, Vij R, et al. Randomized, open label phase 1/2 study of pomalidomide (POM) alone or in combination with low-dose dexamethasone (LoDex) in patients (Pts) with relapsed and refractory multiple myeloma who have received prior treatment that includes lenalidomide (LEN) and bortezomib (BORT): phase 2 results [abstract no. 634]. Blood. 2011;118(21).
11. Celgene Corporation Inc. Celgene Reports Third Quarter 2012 Operating and Financial Results [media release]. 2012. http://www.celgene.com. Accessed 25 Oct 2012.
12. EMA. European Medicines Agency Rare disease (orphan) designations. 2012. http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/landing/ orphan-search.jsp&mid=WC0b01ac058001d12b. Accessed 26 Feb 2013.
13. S Andhavarapu V Roy 2013 Immunomodulatory drugs in multiple myeloma Expert Rev Hematol. 6 1 69 82 23373782 10.1586/ehm.12.62 1:CAS:528: DC%2BC3sXhvV2gsrg%3D
14. GD Ferguson K Jensen-Pergakes C Wilkey, et al. 2007 Immunomodulatory drug CC-4047 is a cell-type and stimulus-selective transcriptional inhibitor of cyclooxygenase 2 J Clin Immunol. 27 2 210 220 17308870 10.1007/s10875-007-9070-6 1:CAS:528:DC%2BD2sXitlCrsL0%3D
15. G Gorgun E Calabrese E Soydan, et al. 2010 Immunomodulatory effects of lenalidomide and pomalidomide on interaction of tumor and bone marrow accessory cells in multiple myeloma Blood. 116 17 3227 3237 20651070 10.1182/blood-2010- 04-279893 1:CAS:528:DC%2BC3cXhsVeisLvF
16. S Lentzsch R LeBlanc K Podar, et al. 2003 Immunomodulatory analogs of thalidomide inhibit growth of Hs Sultan cells and angiogenesis in vivo Leukemia. 17 1 41 44 12529658 10.1038/sj.leu.2402745 1:CAS:528:DC%2BD3sXjsFymtQ%3D%3D
17. YX Zhu E Braggio C-X Shi, et al. 2011 Cereblon expression is required for the antimyeloma activity of lenalidomide and pomalidomide Blood. 118 18 4771 4779 21860026 10.1182/blood-2011-05-356063 1:CAS:528:DC%2BC3MXhsVOgsrjO
18. N Giuliani M Bolzoni M Abeltino, et al. 2010 CC-4047 (pomalidomide) inhibits multiple myeloma-induced osteoclast formation [abstract] Haematologica. 95 383
19. G Anderson M Gries N Kurihara, et al. 2006 Thalidomide derivative CC-4047 inhibits osteoclast formation by down-regulation of PU.1 Blood. 107 8 3098 3105 16373662 10.1182/blood-2005-08-3450 1:CAS:528:DC%2BD28Xjs1Olu70%3D
20. SE Meiler M Wade F Kutlar, et al. 2011 Pomalidomide augments fetal hemoglobin production without the myelosuppressive effects of hydroxyurea in transgenic sickle cell mice Blood. 118 4 1109 1112 21536862 10.1182/blood-2010- 11-319137 1:CAS:528:DC%2BC3MXhtVWltr%2FI
21. Moutouh-de Parseval LA, Verhelle D, Glezer E, et al. Pomalidomide and lenalidomide regulate erythropoiesis and fetal hemoglobin production in human CD34+ cells. J Clin Invest. 2008;118(1):248-58.
22. 14C]pomalidomide in humans following oral administration Cancer Chemother Pharmacol. 71 2 489 501 23203815 10.1007/s00280-012-2040-6 1:CAS:528:DC%2BC3sXhslaktb4%3D
23. Dimopoulos MA, Lacy MQ, Moreau P, et al. Pomalidomide in combination with low-dose dexamethasone: demonstrates a significant progression free survival and overall survival advantage, in relapsed/refractory MM: a phase 3, multicenter, randomized, open-label study [abstract no. LBA-6]. Blood. 2012;120(21).
24. Jagannath S, Hofmeister CC, Siegel DS, et al. Pomalidomide (POM) with low-dose dexamethasone (LoDex) in patients (PTS) with relapsed and refractory multiple myeloma who have received prior therapy with lenalidomide (LEN) and bortezomib (BORT): updated phase 2 results and age subgroup analysis. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
25. Lonial S, Baz R, Bahlis NJ, et al. Improvement in clinical benefit parameters with pomalidomide (POM) in combination with low-dose dexamethasone (LODEX) in patients with relapsed and refractory multiple myeloma (RRMM): results from a phase 2 study. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
26. Richardson PG, Siegel D, Baz R, et al. A phase 1/2 multi-center, randomized, open label dose escalation study to determine the maximum tolerated dose, safety, and efficacy of pomalidomide alone or in combination with low-dose dexamethasone in patients with relapsed and refractory multiple myeloma who have received prior treatment that includes lenalidomide and bortezomib [abstract no. 864]. Blood. 2010;116(21).
27. Lacy MQ, LaPlant BR, Laumann K, et al. Pomalidomide and dexamethasone in relapsed myeloma: results of 225 patients treated in five cohorts over three years. Blood Conference: 53rd Annual Meeting of the American Society of Hematology, ASH. 2011;118(21).
28. MQ Lacy SR Hayman MA Gertz, et al. 2009 Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma J Clin Oncol. 27 30 5008 5014 19720894 10.1200/JCO.2009.23.6802 1:CAS:528:DC%2BD1MXhsVCrsrzE
29. MQ Lacy SR Hayman MA Gertz, et al. 2010 Pomalidomide (CC4047) plus low dose dexamethasone (Pom/dex) is active and well tolerated in lenalidomide refractory multiple myeloma (MM) Leukemia. 24 11 1934 1939 20827286 10.1038/leu.2010.190 1:CAS:528:DC%2BC3cXhtl2gt7vJ
30. MQ Lacy JB Allred MA Gertz, et al. 2011 Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease Blood. 118 11 2970 2975 21690557 10.1182/blood-2011-04-348896 1:CAS:528:DC%2BC3MXht1Ogtb%2FI
31. RA Kyle SV Rajkumar 2009 Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma Leukemia. 23 1 3 9 18971951 10.1038/leu.2008.291 1:STN:280:DC%2BD1M%2FmslOgsA%3D%3D
32. Lacy MQ, Kumar SK, LaPlant BR, et al. Pomalidomide plus low-dose dexamethasone (pom/dex) in relapsed myeloma: Long term follow up and factors predicting outcome in 345 patients. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
33. KD Short SV Rajkumar D Larson, et al. 2011 Incidence of extramedullary disease in patients with multiple myeloma in the era of novel therapy, and the activity of pomalidomide on extramedullary myeloma Leukemia. 25 6 906 908 21350560 10.1038/leu.2011.29 1:CAS:528:DC%2BC3MXntV2isrY%3D
34. Leleu X, Attal M, Arnuff B, et al. Pomalidomide plus low dose dexamethasone is active and well tolerated in bortezomib and lenalidomide refractory multiple myeloma: IFM 2009-02. Blood. 2013.
35. MJ Streetly K Gyertson Y Daniel, et al. 2008 Alternate day pomalidomide retains anti-myeloma effect with reduced adverse events and evidence of in vivo immunomodulation Br J Haematol. 141 1 41 51 18324965 10.1111/j.1365-2141.2008. 07013.x 1:CAS:528:DC%2BD1cXltFGjtr4%3D
36. SA Schey P Fields JB Bartlett, et al. 2004 Phase I study of an immunomodulatory thalidomide analog, CC-4047, in relapsed or refractory multiple myeloma J Clin Oncol. 22 16 3269 3276 15249589 10.1200/JCO.2004.10.052 1:CAS:528:DC%2BD2cXpsVGrsLY%3D
37. Mark TM, Boyer A, Rossi AC, et al. ClaPD (clarithromycin, pomalidomide, dexamethasone) therapy in relapsed or refractory multiple myeloma. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
38. Palumbo A, Larocca A, Montefusco V, et al. Pomalidomide cyclophosphamide and prednisone (PCP) treatment for relapsed/refractory multiple myeloma. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
39. Richardson PG, Hofmeister CC, Siegel D, et al. MM-005: A phase 1, multicenter, open-label, dose-escalation study to determine the maximum tolerated dose for the combination of pomalidomide, bortezomib, and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
40. Shah JJ, Stadtmauer EA, Abonour R, et al. A multi-center phase I/II trial of carfilzomib and pomalidomide with dexamethasone (car-pom-D) in patients with relapsed/refractory multiple myeloma. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
41. Baz R, Shain KH, Alsina M, et al. Oral weekly cyclophosphamide in combination with pomalidomide and dexamethasone for relapsed and refractory myeloma: Report of the dose escalation cohort. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).
42. A Tefferi S Verstovsek G Barosi, et al. 2009 Pomalidomide is active in the treatment of anemia associated with myelofibrosis J Clin Oncol. 27 27 4563 4569 19652059 10.1200/JCO.2008.21.7356 1:CAS:528:DC%2BD1MXhtlCns77E
43. KH Begna RA Mesa A Pardanani, et al. 2011 A phase-2 trial of low-dose pomalidomide in myelofibrosis Leukemia. 25 2 301 304 21052089 10.1038/leu.2010.254 1:CAS:528:DC%2BC3MXhs1ams7g%3D
44. RA Mesa AD Pardanani K Hussein, et al. 2010 Phase1/-2 study of pomalidomide in myelofibrosis Am J Hematol. 85 2 129 130 20052748 1:CAS:528:DC%2BC3cXitlKmsrg%3D
45. KH Begna A Pardanani R Mesa, et al. 2012 Long-term outcome of pomalidomide therapy in myelofibrosis Am J Hematol. 87 1 66 68 22081489 10.1002/ajh.22233 1:CAS:528:DC%2BC3MXhs1egs77J
46. RJ Amato LM Glode J Podolnick, et al. 2011 Phase II study of pomalidomide in patients with castration-resistant prostate cancer Cancers. 3 3 3449 3460 10.3390/cancers3033449 1:CAS:528:DC%2BC3MXht1entbjN
47. A Dispenzieri F Buadi K Laumann, et al. 2012 Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis Blood. 119 23 5397 5404 22493299 10.1182/blood-2012-02-413161 1:CAS:528:DC%2BC38XovFantLc%3D
48. Pusic I, DiPersio JF, Goran SL, et al. Phase-2 study of pomalidomide in advanced corticosteroid-resistant chronic graft-versus-host disease [abstract no. 3326]. Blood. 2009;114(22).
49. I Pusic JF DiPersio SL Goran, et al. 2010 Pomalidomide (POM) in advanced corticosteroid-resistant chronic graft-versus-host disease (CGVHD) Biol Blood Marrow Transpl. 16 2 SUPPL 2 S311 10.1016/j.bbmt.2009.12.462
50. MM Cooney C Nock J Bokar, et al. 2012 Phase I trial of pomalidomide given for patients with advanced solid tumors Cancer Chemother Pharmacol. 70 5 755 761 22875080 10.1007/s00280-012-1919-6 1:CAS:528:DC%2BC38Xhs1Wlur%2FE
51. JR Infante SF Jones JC Bendell, et al. 2011 A phase I, dose-escalation study of pomalidomide (CC-4047) in combination with gemcitabine in metastatic pancreas cancer Eur J Cancer. 47 2 199 205 21051221 10.1016/j.ejca.2010.09.002 1:CAS:528:DC%2BC3MXptVOg
52. MQ Lacy 2011 New immunomodulatory drugs in myeloma Curr Hematol Malig Rep. 6 2 120 125 21327565 10.1007/s11899-011-0077-y
53. Berenson JR, Hilger JD, Klein LM, et al. A phase 1/2 study of pomalidomide, dexamethasone and pegylated liposomal doxorubicin for patients with relapsed/refractory multiple myeloma. Blood Conference: 54th Annual Meeting of the American Society of Hematology, ASH. 2012;120(21).