Affiliation: Food and Drug Administration
- FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspensionEdvardas 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...
- Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypesEdvardas 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...
- 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...
- Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylateMichael 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...