U.S. Food and Drug Administration drug approval summaries: Imatinib mesylate, mesna tablets, and zoledronic acid

Oncologist

Volumn 7, Issue 5, 2002, Pages 393-400

  Cohen, Martin H ^a   Dagher, Ramzi ^a   Griebel, Donna J ^a   Ibrahim, Amna ^a   Martin, Alison ^a   Scher, Nancy S ^a   Sokol, Gerald H ^a   Williams, Grant A ^a   Pazdur, Richard ^a  

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

Author keywords

Bisphosphonates; Bone metastases; Gastrointestinal stromal tumors; Ifosfamide; Imatinib mesylate; Mesna; Zoledronic acid

Indexed keywords

IFOSFAMIDE; IMATINIB; MESNA; PAMIDRONIC ACID; PLACEBO; ZOLEDRONIC ACID;

ABDOMINAL PAIN; BACKACHE; BONE METASTASIS; CLINICAL TRIAL; DIARRHEA; DRUG APPROVAL; DRUG EFFICACY; FATIGUE; FLATULENCE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TUMOR; HEADACHE; HEMORRHAGIC CYSTITIS; HORMONAL THERAPY; HUMAN; INSOMNIA; MULTIPLE MYELOMA; MUSCLE CRAMP; NAUSEA; NEPHROTOXICITY; PRIORITY JOURNAL; RASH; REVIEW; RHINOPHARYNGITIS; SOFT TISSUE SARCOMA; TASTE DISORDER; VOMITING;

EID: 0036413723     PISSN: 10837159     EISSN: None     Source Type: Journal    
DOI: 10.1634/theoncologist.7-5-393     Document Type: Review

References (25)

1. Pidhorecky I, Cheney RT, Kraybill WG et al. Gastrointestinal stromal tumors: Current diagnosis, biologic behavior, and management. Ann Surg Oncol 2000;7:705-712.
2. Hirota S, Isozaki K, Moriyama Y et al. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science 1998;279:577-580.
3. Ashman LK. The biology of stem cell factor and its receptor c-kit. Int J Biochem Cell Biology 1999;31:1037-1051.
4. Lasota J, Jasinski M, Sarlomo-Rikala M et al. Mutations in exon 11 of c-kit occur preferentially in malignant versus benign gastrointestinal stromal tumors and do not occur in leiomyomas or leiomyosarcomas. Am J Pathol 1999;154:53-60.
5. Taniguchi M, Nishida T, Hirota S et al. Effect of c-kit mutation on prognosis of gastrointestinal stromal tumors. Cancer Res 1999;59:4297-4300.
6. Lux ML, Rubin BP, Biase TL et al. KIT extracellular and kinase domain mutations in gastrointestinal stromal tumors. Am J Pathol 2000;156:791-795.
7. Andersson J, Sjogren H, Meis-Kindblom JM et al. The complexity of KIT gene mutations and chromosome rearrangements and their clinical correlation in gastrointestinal stromal (pacemaker cell) tumors. Am J Pathol 2002; 160:15-22.
8. Casper ES. Gastrointestinal stromal tumors. Curr Treat Options Oncol 2000;1:267-273.
9. DeMatteo RP, Lewis JJ, Leung D et al. Two hundred gastrointestinal stromal tumors: Recurrence patterns and prognostic factors for survival. Ann Surg 2000;231:51-58.
10. Conlon KC, Casper ES, Brennan MF., Primary gastrointestinal sarcomas: Analysis of prognostic variables. Ann Surg Oncol 1995;2:26-31.
11. Druker BJ, Lydon NB. Lessons learned from the development of an abl tyrosine kinase inhibitor for chronic myelogenous leukemia. J Clin Invest 2000;105:3-7.
12. Deininger MW, Goldman JM, Melo JV. The molecular biology of chronic myeloid leukemia. Blood 2000;96:3343-3356.
13. Cohen MH, Williams G, Johnson JR et al. Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia. Clin Cancer Res 2002;8:935-942.
14. Joensuu H, Roberts PJ, Sarlomo-Rikala M et al. Effect of the tyrosine kinase inhibitor STI571 in a patient with a metastatic gastrointestinal stromal tumor. N Engl J Med 2001;344:1052-1056.
15. Hensley ML, Schuchter LM, Lindley C et al. American Society of Clinical Oncology clinical practice guidelines for the use of chemotherapy and radiotherapy protectants. J Clin Oncol 1999;17:3333-3355.
16. Brock N, Pohl J, Stekar J et al. Studies on the urotoxicity of oxazaphosphorine cytostatics and its prevention - III. Profile of action of sodium 2-mercaptoethane sulfonate (mesna). Eur J Cancer Clin Oncol 1982; 18:1377-1387.
17. Fukuoka M, Negoro S, Masuda N et al. Placebo-controlled double-blind comparative study on the preventive efficacy of mesna against ifosfamide-induced urinary disorders. J Cancer Res Clin Oncol 1991;117:473-478.
18. Shaw IC. Mesna and oxazaphosphorine cancer chemotherapy. Cancer Treat Rev 1987;14:359-364.
19. Souid AK, Fahey RC, Aktas MK et al. Blood thiols following amifostine and mesna infusions, a Pediatric Oncology Group study. Drug Metab Dispos 2001;29:1460-1466.
20. Goren MP, Houle JM, Bush DA. Similar bioavailability of single-dose oral and intravenous mesna in the blood and urine of healthy human subjects. Clin Cancer Res 1998;4:2313-2320.
21. Goren MP, Hsu LC, Li JT. Reduction of dimesna to mesna by the isolated perfused rat liver. Cancer Res 1998;58:4358-4362.
22. Flanagan AM, Chambers TJ. Inhibition of bone resorption by bisphosphonates: Interactions between bisphosphonates, osteoclasts, and bone. Calcif Tissue Int 1991;49:407-415.
23. Berenson JR, Lichtenstein A, Porter L et al. Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. Myeloma Aredia Study Group. J Clin Oncol 1998;16:593-602.
24. Hortobagyi GN, Theriault RL, Lipton A et al. Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. Protocol 19 Aredia Breast Cancer Study Group. J Clin Oncol 1998;16:2038-2044.
25. Scher HI, Chung WK. Bone metastases: Improving the therapeutic index. Semin Oncol 1994;21:630-656.