Ramzi Dagher

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint 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 study
    Ramzi Dagher
    Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA
    Med Pediatr Oncol 38:158-64. 2002
  2. ncbi request reprint Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
    Ramzi Dagher
    Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:3034-8. 2002
  3. ncbi request reprint Accelerated approval of oncology products: a decade of experience
    Ramzi 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
  4. ncbi request reprint Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer
    Ramzi 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
  5. doi request reprint Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy
    Maitreyee 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
  6. ncbi request reprint Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma
    Yang 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
  7. doi request reprint Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib
    Maitreyee 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
  8. ncbi request reprint Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma
    Vicki 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
  9. ncbi request reprint Bortezomib for the treatment of mantle cell lymphoma
    Robert 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
  10. ncbi request reprint U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid
    Martin 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

Detail Information

Publications15

  1. ncbi request reprint 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 study
    Ramzi 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...
  2. ncbi request reprint Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
    Ramzi Dagher
    Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:3034-8. 2002
    ....
  3. ncbi request reprint Accelerated approval of oncology products: a decade of experience
    Ramzi 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
    ....
  4. ncbi request reprint Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer
    Ramzi 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...
  5. doi request reprint Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy
    Maitreyee 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...
  6. ncbi request reprint Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma
    Yang 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...
  7. doi request reprint Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib
    Maitreyee 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
    ....
  8. ncbi request reprint Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma
    Vicki 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...
  9. ncbi request reprint Bortezomib for the treatment of mantle cell lymphoma
    Robert 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...
  10. ncbi request reprint U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid
    Martin 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...
  11. doi request reprint Dexrazoxane (Totect): FDA review and approval for the treatment of accidental extravasation following intravenous anthracycline chemotherapy
    Robert 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...
  12. doi request reprint Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapies
    Robert 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...
  13. ncbi request reprint Topotecan in combination with cisplatin for the treatment of stage IVB, recurrent, or persistent cervical cancer
    Michael 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...
  14. ncbi request reprint Food and Drug Administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma
    Edwin 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...
  15. ncbi request reprint Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphoma
    Bhupinder 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)...