P F Bross

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia
    P F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Clin Cancer Res 7:1490-6. 2001
  2. ncbi request reprint FDA drug approval summaries: fulvestrant
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, MD 20857, USA
    Oncologist 7:477-80. 2002
  3. ncbi request reprint Fulvestrant in postmenopausal women with advanced breast cancer
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Clin Cancer Res 9:4309-17. 2003
  4. ncbi request reprint Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapy
    Robert 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
  5. ncbi request reprint Approval summary for bortezomib for injection in the treatment of multiple myeloma
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland, USA
    Clin Cancer Res 10:3954-64. 2004

Detail Information

Publications5

  1. ncbi request reprint Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia
    P F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Clin Cancer Res 7:1490-6. 2001
    ..In this study, we review the preclinical and clinical profiles of this immunoconjugate and the regulatory review that led to marketing approval by the United States Food and Drug Administration...
  2. ncbi request reprint FDA drug approval summaries: fulvestrant
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, MD 20857, USA
    Oncologist 7:477-80. 2002
    ..Approval was based on similarity of response rates and time to progression between fulvestrant and anastrozole...
  3. ncbi request reprint Fulvestrant in postmenopausal women with advanced breast cancer
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Clin Cancer Res 9:4309-17. 2003
    ..In this report, we describe the data and analyses supporting marketing approval for FVT by the United States Food and Drug Administration (FDA)...
  4. ncbi request reprint Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapy
    Robert 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...
  5. ncbi request reprint Approval summary for bortezomib for injection in the treatment of multiple myeloma
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland, USA
    Clin Cancer Res 10:3954-64. 2004