Research Topics
| Ramzi DagherSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Detail Information
Publications
Pilot trial of tumor-specific peptide vaccination and continuous infusion interleukin-2 in patients with recurrent Ewing sarcoma and alveolar rhabdomyosarcoma: an inter-institute NIH studyRamzi Dagher
Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA
Med Pediatr Oncol 38:158-64. 2002..We have investigated the use of peptide pulsed vaccination in an attempt to immunologically target the breakpoint region of tumor specific fusion proteins expressed in these tumors...- Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumorsRamzi Dagher
Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 8:3034-8. 2002.... - Accelerated approval of oncology products: a decade of experienceRamzi Dagher
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, USA
J Natl Cancer Inst 96:1500-9. 2004.... - Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancerRamzi Dagher
Division of Oncology Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 10:8147-51. 2004..The purpose of this summary is to review the database supporting this approval... 
Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapyMaitreyee Hazarika
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
Oncologist 13:1120-7. 2008..The FDA approved lenalidomide with a restricted distribution program, RevAssist...- Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myelomaYang Min Ning
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring, Maryland 20993 0004, USA
Oncology (Williston Park) 21:1503-8; discussion 1511, 1513, 1516 passim. 2007..Here we summarize the FDA review of the data that support this approval... - Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinibMaitreyee Hazarika
Office of Oncology Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993, USA
Clin Cancer Res 14:5325-31. 2008.... - Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinomaVicki L Goodman
Division of Drug Oncology Products, U S Food and Drug Administration, Sliver Spring, Maryland 20903, USA
Clin Cancer Res 13:1367-73. 2007..Additionally, sunitinib received accelerated approval for the treatment of advanced renal cell carcinoma... - Bortezomib for the treatment of mantle cell lymphomaRobert C Kane
Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
Clin Cancer Res 13:5291-4. 2007..To describe the Food and Drug Administration review and marketing approval considerations for bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma... - U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acidMartin H Cohen
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
Oncologist 7:393-400. 2002..Information provided includes rationale for drug development, study design, efficacy and safety results, and pertinent literature references... - Dexrazoxane (Totect): FDA review and approval for the treatment of accidental extravasation following intravenous anthracycline chemotherapyRobert C Kane
Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Room 2109, Silver Spring, Maryland 20993 0002, USA
Oncologist 13:445-50. 2008..For this uncommon but serious complication of anthracycline therapy, the need for surgical intervention was 1.7% with this regimen... - Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapiesRobert J Lechleider
Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20903, USA
Clin Cancer Res 14:4378-84. 2008..To describe the considerations leading to marketing approval of ixabepilone in combination with capecitabine and as monotherapy for the treatment of advanced breast cancer that is refractory to other chemotherapies... - Topotecan in combination with cisplatin for the treatment of stage IVB, recurrent, or persistent cervical cancerMichael Brave
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
Oncology (Williston Park) 20:1401-4, 1410; discussion 1410-11, 1415-6. 2006..The purpose of this summary is to review the database supporting this approval... - Food and Drug Administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinomaEdwin P Rock
Food and Drug Administration, Division of Drug Oncology Products, 10903 New Hampshire Avenue, Bldg 22, Rm 2133, Silver Spring, Maryland 20903, USA
Oncologist 12:107-13. 2007..Caution should be exercised when administering sunitinib in combination with known CYP3A4 inducers or inhibitors... - Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphomaBhupinder S Mann
Food and Drug Administration, Silver Spring, Maryland 20993, USA
Clin Cancer Res 13:2318-22. 2007..To discuss vorinostat approval for treatment of cutaneous manifestations of advanced cutaneous T-cell lymphoma (CTCL)...