Edvardas Kaminskas

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension
    Edvardas Kaminskas
    U S Food and Drug Administration, 5600 Fishers Lane, HFD 150, Rockville, Maryland 20857, USA
    Oncologist 10:176-82. 2005
  2. ncbi Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes
    Edvardas Kaminskas
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
    Clin Cancer Res 11:3604-8. 2005
  3. ncbi 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
  4. ncbi Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate
    Michael Brave
    Office of Oncology Drug Products, Office of New Drugs, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
    Clin Cancer Res 14:352-9. 2008

Collaborators

Detail Information

Publications4

  1. ncbi FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension
    Edvardas Kaminskas
    U S Food and Drug Administration, 5600 Fishers Lane, HFD 150, Rockville, Maryland 20857, USA
    Oncologist 10:176-82. 2005
    ..S. FDA for MDS, has a favorable safety profile and provides a clinical benefit of eliminating transfusion dependence and complete or partial normalization of blood counts and bone marrow blast percentages in responding patients...
  2. ncbi Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes
    Edvardas Kaminskas
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
    Clin Cancer Res 11:3604-8. 2005
    ..S. Food and Drug Administration for marketing approval of azacitidine as injectable suspension (Vidaza, Pharmion Corporation, Boulder, CO) for treatment of patients with myelodysplastic syndrome...
  3. ncbi 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...
  4. ncbi Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate
    Michael Brave
    Office of Oncology Drug Products, Office of New Drugs, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
    Clin Cancer Res 14:352-9. 2008
    ..This summary reviews the database supporting this approval...