Patricia Keegan

Patricia Keegan

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Patricia Keegan

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FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors.

Clin Cancer Res 2019 Jul 20;25(13):3753-3758. Epub 2019 Feb 20.

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-18-4070DOI Listing
July 2019

Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer.

JAMA Oncol 2019 Jul 25. Epub 2019 Jul 25.

Oncology Center of Excellence, Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jamaoncol.2019.1747DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6659150PMC
July 2019

Mean Aortic pressure gradient and global longitudinal strain recovery after transcatheter aortic valve replacement - A retrospective analysis.

Hellenic J Cardiol 2018 Sep - Oct;59(5):268-271. Epub 2018 Jan 31.

Emory Structural Heart & Valve Center, Emory University Hospital, 1364 Clifton Road NE, Atlanta, GA, 30322, USA. Electronic address:

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http://dx.doi.org/10.1016/j.hjc.2018.01.006DOI Listing
June 2019

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.

J Natl Cancer Inst 2019 May;111(5):449-458

Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration.

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http://dx.doi.org/10.1093/jnci/djy130DOI Listing
May 2019

Balloon expandable transcatheter aortic valve replacement outcomes by procedure location: Catheterization laboratory versus operating room.

Cardiovasc Revasc Med 2019 Apr 30. Epub 2019 Apr 30.

Emory Structural Heart and Valve Center, Emory University School of Medicine, Atlanta, GA, USA.

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http://dx.doi.org/10.1016/j.carrev.2019.04.007DOI Listing
April 2019

FDA's Approval of the First Biosimilar to Bevacizumab.

Clin Cancer Res 2018 09 9;24(18):4365-4370. Epub 2018 May 9.

Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-18-0566DOI Listing
September 2018

Anti-PD-1 antibody treatment for melanoma - Authors' reply.

Lancet Oncol 2018 05;19(5):e220

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.1016/S1470-2045(18)30251-1DOI Listing
May 2018

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen.

Clin Cancer Res 2017 Nov 27;23(21):6384-6389. Epub 2017 Feb 27.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-2422DOI Listing
November 2017

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma.

Clin Cancer Res 2017 Oct 8;23(19):5661-5665. Epub 2017 Feb 8.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-0664DOI Listing
October 2017

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.

Clin Cancer Res 2017 Oct 24;23(19):5666-5670. Epub 2017 Feb 24.

Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-0663DOI Listing
October 2017

FDA Approval Summary: Sonidegib-Response.

Clin Cancer Res 2017 10;23(19):5994

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-17-2135DOI Listing
October 2017

First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication.

N Engl J Med 2017 Oct;377(15):1409-1412

From the Office of Hematology and Oncology Products (S.L., P.K.) and the Oncology Center of Excellence (R.P.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1056/NEJMp1709968DOI Listing
October 2017

Readmission rates after transcatheter aortic valve replacement in high- and extreme-risk patients with severe aortic stenosis.

J Thorac Cardiovasc Surg 2017 08 18;154(2):445-452. Epub 2017 Apr 18.

Division of Cardiothoracic Surgery, Structural Heart and Valve Center, Emory University, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2017.03.144DOI Listing
August 2017

FDA Approval Summary: TAS-102.

Clin Cancer Res 2017 Jun 17;23(12):2924-2927. Epub 2017 Feb 17.

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-2157DOI Listing
June 2017

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma.

Clin Cancer Res 2017 May 10;23(10):2377-2381. Epub 2017 Jan 10.

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://clincancerres.aacrjournals.org/content/early/2017/01/
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http://dx.doi.org/10.1158/1078-0432.CCR-16-2051DOI Listing
May 2017

End-stage renal disease and severe aortic stenosis: Does valve replacement improve one-year outcomes?

Catheter Cardiovasc Interv 2017 May 17;89(6):1109-1115. Epub 2017 Feb 17.

Structural Heart and Valve Center, Divisions of Cardiology, Emory University School of Medicine, Atlanta, Georgia.

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http://dx.doi.org/10.1002/ccd.26875DOI Listing
May 2017

FDA's Approach to Regulating Biosimilars.

Clin Cancer Res 2017 04 29;23(8):1882-1885. Epub 2016 Dec 29.

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-1354DOI Listing
April 2017

Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1-defined disease progression in clinical trials.

Semin Oncol 2017 Feb 10;44(1):3-7. Epub 2017 Feb 10.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1053/j.seminoncol.2017.01.001DOI Listing
February 2017

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.

Clin Cancer Res 2016 Nov 31;22(21):5167-5170. Epub 2016 Aug 31.

Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://clincancerres.aacrjournals.org/content/early/2016/10/
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http://dx.doi.org/10.1158/1078-0432.CCR-16-1010DOI Listing
November 2016

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.

Clin Cancer Res 2016 11;22(22):5618

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-2140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895452PMC
November 2016

FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy.

Oncologist 2016 05 16;21(5):634-42. Epub 2016 Mar 16.

Office of Hematology and Oncology Products and Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1634/theoncologist.2015-0507DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4861371PMC
May 2016

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1.

Oncologist 2016 05 29;21(5):643-50. Epub 2016 Mar 29.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1634/theoncologist.2015-0498DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4861368PMC
May 2016

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.

Clin Cancer Res 2016 Apr 12;22(7):1553-8. Epub 2016 Jan 12.

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-15-2035DOI Listing
April 2016

Clinical outcome assessments in neuro-oncology: a regulatory perspective.

Neurooncol Pract 2016 Mar 27;3(1):4-9. Epub 2015 Dec 27.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (J.S., P.G.K., P.K.); Clinical Outcome Assessments Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (E.J.P.).

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http://dx.doi.org/10.1093/nop/npv062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760344PMC
March 2016

FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer.

Clin Cancer Res 2016 Mar;22(6):1307-12

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-15-2266DOI Listing
March 2016

Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.

JAMA Oncol 2016 Jan;2(1):118-22

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jamaoncol.2015.3934DOI Listing
January 2016

FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer.

Clin Cancer Res 2015 Dec 31;21(23):5205-8. Epub 2015 Aug 31.

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-15-1377DOI Listing
December 2015

Outcomes for Transcatheter Aortic Valve Replacement in Nonagenarians.

Ann Thorac Surg 2015 Oct 16;100(4):1261-7; discussion 1267. Epub 2015 Jul 16.

Structural Heart and Valve Center, Division of Cardiology, Department of Medicine, Emory University, Atlanta, Georgia.

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http://dx.doi.org/10.1016/j.athoracsur.2015.04.037DOI Listing
October 2015

Minimalist transcatheter aortic valve replacement: The new standard for surgeons and cardiologists using transfemoral access?

J Thorac Cardiovasc Surg 2015 Oct 30;150(4):833-9. Epub 2015 Jul 30.

Division of Cardiothoracic Surgery, Joseph B. Whitehead Department of Surgery, Emory Structural Heart and Valve Center, Emory University Hospital and Emory University Hospital Midtown, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2015.07.078DOI Listing
October 2015

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

Clin Cancer Res 2015 Oct;21(20):4545-51

Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-14-3244DOI Listing
October 2015

FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements.

Oncologist 2014 Oct 28;19(10):e5-11. Epub 2014 Aug 28.

Office of Hematology and Oncology Products and Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1634/theoncologist.2014-0241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4201002PMC
October 2014

Reply to Letter to the Editor: Local Evaluation and Blinded Central Review Comparison a Victim of Meta-analysis Shortcomings.

Ther Innov Regul Sci 2014 Mar;48(2):NP1-NP2

2 Division of Biometrics V, Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479014520698DOI Listing
March 2014

U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma.

Oncologist 2012 21;17(10):1323-8. Epub 2012 Sep 21.

Division of Biological Oncology Products, Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 5222, Silver Spring, Maryland 20993, USA.

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http://theoncologist.alphamedpress.org/cgi/doi/10.1634/theon
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http://dx.doi.org/10.1634/theoncologist.2012-0123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481898PMC
June 2013

U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma.

Clin Cancer Res 2013 May 20;19(9):2289-93. Epub 2013 Mar 20.

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://clincancerres.aacrjournals.org/content/19/9/2289.full
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http://clincancerres.aacrjournals.org/cgi/doi/10.1158/1078-0
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http://dx.doi.org/10.1158/1078-0432.CCR-12-1956DOI Listing
May 2013

Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis.

Ther Innov Regul Sci 2013 Mar;47(2):167-174

1 Division of Biometrics V, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/0092861512459733DOI Listing
March 2013

The combination of exposure-response and case-control analyses in regulatory decision making.

J Clin Pharmacol 2013 Feb 24;53(2):160-6. Epub 2013 Jan 24.

Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, MD 20903, USA.

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http://doi.wiley.com/10.1177/0091270012445206
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http://dx.doi.org/10.1177/0091270012445206DOI Listing
February 2013

US Food and Drug Administration approval overview in metastatic breast cancer.

J Clin Oncol 2012 May 19;30(14):1705-11. Epub 2012 Mar 19.

US Food and Drug Administration, Silver Spring, MD 20993-0002, USA.

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http://dx.doi.org/10.1200/JCO.2011.39.2613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3383116PMC
May 2012

The risks and benefits of 5α-reductase inhibitors for prostate-cancer prevention.

N Engl J Med 2011 Jul 15;365(2):97-9. Epub 2011 Jun 15.

Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1056/NEJMp1106783DOI Listing
July 2011

U.S. Food and drug administration approval: rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia.

Oncologist 2011 6;16(1):97-104. Epub 2011 Jan 6.

Division of Biological Oncology Products, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 5223, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1634/theoncologist.2010-0306DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228054PMC
June 2011

Accelerated approval of oncology products: the food and drug administration experience.

J Natl Cancer Inst 2011 Apr 21;103(8):636-44. Epub 2011 Mar 21.

Division of Drug Oncology Products, Office of Oncology Drug Products, 10903 New Hampshire Ave, Bldg 22, Rm 2117, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.1093/jnci/djr062DOI Listing
April 2011

FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma.

Oncologist 2010 8;15(1):104-11. Epub 2010 Jan 8.

U.S. Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2113, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1634/theoncologist.2009-0250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227879PMC
May 2010

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

J Natl Cancer Inst 2010 Feb 29;102(4):230-43. Epub 2010 Jan 29.

Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.

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https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnc
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http://dx.doi.org/10.1093/jnci/djp515DOI Listing
February 2010

FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme.

Oncologist 2009 Nov 6;14(11):1131-8. Epub 2009 Nov 6.

Division of Biological 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.

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http://dx.doi.org/10.1634/theoncologist.2009-0121DOI Listing
November 2009

FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer.

Oncologist 2009 Mar 12;14(3):284-90. Epub 2009 Mar 12.

Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.1634/theoncologist.2008-0254DOI Listing
March 2009

Continuing reassessment of the risks of erythropoiesis-stimulating agents in patients with cancer.

Clin Cancer Res 2008 Jun;14(11):3242-7

Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-07-1872DOI Listing
June 2008

FDA drug approval summary: alemtuzumab as single-agent treatment for B-cell chronic lymphocytic leukemia.

Oncologist 2008 Feb;13(2):167-74

P.A.-C., U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1634/theoncologist.2007-0218DOI Listing
February 2008

FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL).

Oncologist 2007 Aug;12(8):991-8

U.S. Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2102, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1634/theoncologist.12-8-991DOI Listing
August 2007

FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer.

Oncologist 2007 Jun;12(6):713-8

Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA.

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http://theoncologist.alphamedpress.org/cgi/doi/10.1634/theon
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http://dx.doi.org/10.1634/theoncologist.12-6-713DOI Listing
June 2007

FDA drug approval summary: panitumumab (Vectibix).

Oncologist 2007 May;12(5):577-83

Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://theoncologist.alphamedpress.org/content/12/5/577.full
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http://theoncologist.alphamedpress.org/cgi/doi/10.1634/theon
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http://dx.doi.org/10.1634/theoncologist.12-5-577DOI Listing
May 2007

FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer.

Oncologist 2007 Mar;12(3):356-61

Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD-150, 5600 Fishers Lane, Rockville, Maryland 20857, USA.

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http://dx.doi.org/10.1634/theoncologist.12-3-356DOI Listing
March 2007

Development and regulation of monoclonal antibody products: challenges and opportunities.

Cancer Metastasis Rev 2005 Dec;24(4):569-84

Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1007/s10555-005-6196-yDOI Listing
December 2005

Accelerated approval of oncology products: a decade of experience.

J Natl Cancer Inst 2004 Oct;96(20):1500-9

Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1093/jnci/djh279DOI Listing
October 2004