Research Topics
Species | John R JohnsonSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Publications
End points and United States Food and Drug Administration approval of oncology drugsJohn R Johnson
Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, MD 20857, USA
J Clin Oncol 21:1404-11. 2003..To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years...- Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phaseJohn R Johnson
Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 9:1972-9. 2003.... 
Accelerated approval of oncology products: the food and drug administration experienceJohn R Johnson
Division of Drug Oncology Products, Office of Oncology Drug Products, 10903 New Hampshire Ave, Bldg 22, Rm 2117, Silver Spring, MD 20993, USA
J Natl Cancer Inst 103:636-44. 2011....- Approval summary for erlotinib for treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimenJohn R Johnson
Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, MD 20857, USA
Clin Cancer Res 11:6414-21. 2005.... - Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifenBhupinder S Mann
Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 11:5671-7. 2005.... - Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemiaMartin H Cohen
Division Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 8:935-42. 2002..In this report, we describe the preclinical profile of imatinib and the data submitted in the New Drug Application that led to its marketing approval... - Pemetrexed in malignant pleural mesotheliomaMaitreyee Hazarika
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
Clin Cancer Res 11:982-92. 2005..Indianapolis, IN) by the U.S. Food and Drug Administration (FDA) of a New Drug Application for the treatment of malignant pleural mesothelioma (MPM)... - FDA drug approval summary: erlotinib (Tarceva) tabletsMartin H Cohen
Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
Oncologist 10:461-6. 2005..In the first-line treatment of NSCLC, two large, controlled, randomized trials showed no benefit from adding erlotinib to doublet, platinum-based chemotherapy. Therefore, erlotinib is not indicated for use in this setting... - FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancerMartin H Cohen
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
Oncologist 10:363-8. 2005..Of greatest importance, pemetrexed caused significantly less neutropenia, febrile neutropenia, neutropenic infections, and need for granulocyte/macrophage colony-stimulating factors... 
Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approvalMartin H Cohen
Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
Oncologist 16:1762-70. 2011..Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen...- FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphomaBhupinder S Mann
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland, USA
Oncologist 12:1247-52. 2007..Grade 3 or greater chemistry abnormalities included hyperglycemia, hypertriglyceridemia, and hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, hyperkalemia, hypercholesterolemia, hypophosphatemia, and increased creatinine... - Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC)Martin H Cohen
Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
Oncologist 15:1344-51. 2010..In total, 59% of placebo-treated patients who received treatment received FDA approved second-line NSCLC drugs. The most common adverse reactions in patients receiving erlotinib were rash and diarrhea... - Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreasAdrian M Senderowicz
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
Oncology (Williston Park) 21:1696-706; discussion 1706-9, 1712, 1715. 2007..Physicians and patients now have a new option for the treatment of locally advanced/metastatic adenocarcinoma of the pancreas... - Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiformeMartin H Cohen
Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 11:6767-71. 2005..1 months (radiotherapy alone). Adverse events during temozolomide treatment included thrombocytopenia, nausea, vomiting, anorexia, constipation, alopecia, headache, fatigue, and convulsions... - Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphomaBhupinder 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)... - Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007Rajeshwari Sridhara
Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA
J Natl Cancer Inst 102:230-43. 2010..We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007... - Approval summary: imatinib mesylate for one or three years in the adjuvant treatment of gastrointestinal stromal tumorsMartin H Cohen
U S Food and Drug Administration, Silver Spring, MD 20993 0002, USA
Oncologist 17:992-7. 2012..The most common adverse reactions, as noted in previous imatinib studies, were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting, and abdominal pain... - U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approvalMartin H Cohen
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 11:12-9. 2005.... - FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphomaMartin H Cohen
Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA
Oncologist 13:709-14. 2008.... - Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphomaMartin H Cohen
Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Clin Cancer Res 12:5329-35. 2006.... - FDA drug approval summaries: pemetrexed (Alimta)Maitreyee Hazarika
U S Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
Oncologist 9:482-8. 2004..Patients should also receive corticosteroids with chemotherapy to reduce the risk of skin rashes. Approval was based on superior survival as a clinical benefit... - Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancerMartin H Cohen
Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 8:665-9. 2002..The manufacturer made a commitment to provide updated information on survival... - The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicityRoshni P Ramchandani
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, WO21 Rm 3667, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
J Clin Pharmacol 47:78-86. 2007..The label modifications also included recommendations for lower starting doses of irinotecan in patients homozygous for the UGT1A1*28 (7/7) polymorphism... - Clinical outcomes in older patients after posterolateral lumbar fusionSteven D Glassman
Department of Orthopaedic Surgery, University of Louisville School of Medicine and the Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202, USA
Spine J 7:547-51. 2007....