Regulatory Issues: FDA

The following activities are available for studies related to the effect of regulatory decisions on oncology clinical practice.

• FDA Drug Approval Summary: Nelarabine (Arranon^®). for the Treatment of T-Cell Lymphoblastic Leukemia/Lymphoma
• Dexrazoxane (Totect^™): FDA Review and Approval for the Treatment of Accidental Extravasation Following Intravenous Anthracycline Chemotherapy
• FDA Drug Approval Summary: Alemtuzumab as Single-Agent Treatment for B-Cell Chronic Lymphocytic Leukemia
• FDA Approval Summary: Vorinostat for Treatment of Advanced Primary Cutaneous T-Cell Lymphoma
• FDA Drug Approval Summary: Pegaspargase (Oncaspar^®) for the First-Line Treatment of Children With Acute Lymphoblastic Leukemia (ALL)
• FDA Drug Approval Summary: Bevacizumab (Avastin^®) Plus Carboplatin and Paclitaxel as First-Line Treatment of Advanced/Metastatic Recurrent Nonsquamous Non-Small Cell Lung Cancer
• FDA Drug Approval Summary: Panitumumab (Vectibix^TM)
• FDA Drug Approval Summary: Bevacizumab Plus FOLFOX4 as Second Line Treatment of Colorectal Cancer
• Food and Drug Administration Drug Approval Summary: Sunitinib Malate for the Treatment of Gastrointestinal Stromal Tumor and Advanced Renal Cell Carcinoma
• FDA Drug Approval Summary: Pemetrexed for Injection (Alimta®) for the Treatment of Non-Small Cell Lung Cancer EXPIRED
• FDA Drug Approval Summary: Azacitidine (5-azacytidine, Vidaza^TM) for Injectable Suspension EXPIRED
• FDA Drug Approval Summaries: Pemetrexed (Alimta®) EXPIRED
• FDA Drug Approval Summaries: Oxaliplatin EXPIRED