John R Johnson

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint End points and United States Food and Drug Administration approval of oncology drugs
    John 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
  2. ncbi request reprint Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase
    John 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
  3. doi request reprint Accelerated approval of oncology products: the food and drug administration experience
    John 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
  4. ncbi request reprint 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 regimen
    John 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
  5. ncbi request reprint Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen
    Bhupinder 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
  6. ncbi request reprint Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia
    Martin 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
  7. ncbi request reprint Pemetrexed in malignant pleural mesothelioma
    Maitreyee 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
  8. ncbi request reprint FDA drug approval summary: erlotinib (Tarceva) tablets
    Martin 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
  9. ncbi request reprint FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer
    Martin 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
  10. pmc Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval
    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 16:1762-70. 2011

Detail Information

Publications24

  1. ncbi request reprint End points and United States Food and Drug Administration approval of oncology drugs
    John 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...
  2. ncbi request reprint Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase
    John 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
    ....
  3. doi request reprint Accelerated approval of oncology products: the food and drug administration experience
    John 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
    ....
  4. ncbi request reprint 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 regimen
    John 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
    ....
  5. ncbi request reprint Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen
    Bhupinder 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
    ....
  6. ncbi request reprint Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia
    Martin 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...
  7. ncbi request reprint Pemetrexed in malignant pleural mesothelioma
    Maitreyee 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)...
  8. ncbi request reprint FDA drug approval summary: erlotinib (Tarceva) tablets
    Martin 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...
  9. ncbi request reprint FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer
    Martin 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...
  10. pmc Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval
    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 16:1762-70. 2011
    ..Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen...
  11. ncbi request reprint FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma
    Bhupinder 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...
  12. pmc 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...
  13. ncbi request reprint Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas
    Adrian 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...
  14. ncbi request reprint Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme
    Martin 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...
  15. ncbi request reprint Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphoma
    Bhupinder 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)...
  16. pmc Approval summary: imatinib mesylate for one or three years in the adjuvant treatment of gastrointestinal stromal tumors
    Martin 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...
  17. ncbi request reprint U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval
    Martin 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
    ..The present review, based on a safety and efficacy report submitted on December 20, 2002, summarizes data applicable to the conversion of these three CML indications to full approval status...
  18. doi request reprint Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007
    Rajeshwari 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...
  19. doi request reprint FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma
    Martin 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
    ....
  20. ncbi request reprint Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma
    Martin 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
    ....
  21. ncbi request reprint 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...
  22. ncbi request reprint Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer
    Martin 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...
  23. ncbi request reprint The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity
    Roshni 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...
  24. ncbi request reprint Clinical outcomes in older patients after posterolateral lumbar fusion
    Steven 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
    ....