Research Topics
| Robert C KaneSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Detail Information
Publications
United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapyRobert C Kane
Division of Drug Oncology Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0004, USA
Clin Cancer Res 12:2955-60. 2006..The FDA analysis of the trial data and bortezomib's regulatory development are summarized here...
Sorafenib for the treatment of advanced renal cell carcinomaRobert C Kane
Division of Drug Oncology Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0004, USA
Clin Cancer Res 12:7271-8. 2006..S. Food and Drug Administration (FDA) review and approval of sorafenib (Nexavar, BAY43-9006), a new small-molecule, oral, multi-kinase inhibitor for the treatment of patients with advanced renal cell carcinoma (RCC)...
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...
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...
The clinical significance of statistical significanceRobert C Kane
Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
Oncologist 13:1129-33. 2008....
Sorafenib for the treatment of unresectable hepatocellular carcinomaRobert C Kane
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0004, USA
Oncologist 14:95-100. 2009..Montville, NJ, and Onyx Pharmaceuticals Corp., Emeryville, CA), an oral kinase inhibitor, for the treatment of patients with unresectable hepatocellular carcinoma (HCC)...
Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapyRobert C Kane
Division of Oncology Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland, USA
Oncologist 8:508-13. 2003..This report highlights the FDA analysis supporting the accelerated approval...
