Amy E McKee

Amy E McKee

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Amy E McKee

Amy E McKee

Publications by authors named "Amy E McKee"

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Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities.

Pediatr Blood Cancer 2019 Aug 30;66(8):e27809. Epub 2019 May 30.

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

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http://dx.doi.org/10.1002/pbc.27809DOI Listing
August 2019

Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology.

Clin Pharmacol Ther 2019 Jul 5;106(1):81-83. Epub 2019 Apr 5.

US Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1002/cpt.1421DOI Listing
July 2019

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma.

Clin Cancer Res 2019 Mar 9;25(6):1702-1708. Epub 2018 Nov 9.

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

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http://clincancerres.aacrjournals.org/lookup/doi/10.1158/107
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http://dx.doi.org/10.1158/1078-0432.CCR-18-2743DOI Listing
March 2019

FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia.

Oncologist 2018 11 17;23(11):1366-1371. Epub 2018 Jul 17.

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.2018-0179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291336PMC
November 2018

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

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma.

Oncologist 2018 06 7;23(6):734-739. Epub 2018 Feb 7.

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.2017-0440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6067941PMC
June 2018

Complexity of Delivering Precision Medicine: Opportunities and Challenges.

Am Soc Clin Oncol Educ Book 2018 May;38:998-1007

From the Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC.

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http://dx.doi.org/10.1200/EDBK_200279DOI Listing
May 2018

Breakthrough-Therapy Designation - An FDA Perspective.

N Engl J Med 2018 04;378(15):1457-1458

Food and Drug Administration, Silver Spring, MD

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http://dx.doi.org/10.1056/NEJMc1801222DOI Listing
April 2018

The FDA Oncology Center of Excellence and precision medicine.

Exp Biol Med (Maywood) 2018 02 6;243(3):308-312. Epub 2017 Nov 6.

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

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http://journals.sagepub.com/doi/10.1177/1535370217740861
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http://dx.doi.org/10.1177/1535370217740861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813869PMC
February 2018

Report on the Third FDA-AACR Oncology Dose-Finding Workshop.

Cancer Immunol Res 2017 12;5(12):1058-1061

U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/2326-6066.CIR-17-0590DOI Listing
December 2017

How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?

J Clin Pharmacol 2017 Oct;57 Suppl 10:S136-S142

Office of Public Health Strategy and Analysis, Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1002/jcph.960DOI Listing
October 2017

Regulatory considerations on endpoints in ovarian cancer drug development.

Cancer 2017 Jul 12;123(14):2604-2608. Epub 2017 May 12.

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

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http://dx.doi.org/10.1002/cncr.30652DOI Listing
July 2017

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.

Oncologist 2017 07 2;22(7):762-767. Epub 2017 Jun 2.

Office of Hematology 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.2017-0152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5507655PMC
July 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

Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle.

Clin Cancer Res 2016 06;22(11):2613-7

U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-15-2643DOI Listing
June 2016

Successes and Challenges of PARP Inhibitors in Cancer Therapy.

Front Oncol 2015 14;5:222. Epub 2015 Oct 14.

Office of Hematology and Oncology Products (OHOP), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration , Silver Spring, MD , USA.

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http://dx.doi.org/10.3389/fonc.2015.00222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604313PMC
November 2015

The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

Oncologist 2010 ;15 Suppl 1:13-8

U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1634/theoncologist.2010-S1-13DOI Listing
July 2010

On Trk--the TrkB signal transduction pathway is an increasingly important target in cancer biology.

Clin Cancer Res 2009 Oct 15;15(19):5962-7. Epub 2009 Sep 15.

Cell and Molecular Biology Section, Pediatric Oncology Branch, Center for Cancer Research, CRC, NCI, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-08-0651DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2756331PMC
October 2009

Targeting caspase 8 to reduce the formation of metastases in neuroblastoma.

Expert Opin Ther Targets 2006 Oct;10(5):703-8

National Cancer Institute, NIH, Cell & Molecular Biology Section, Paediatric Oncology Branch, 10 Center Drive, Building 10/CRC, Room 1-5816, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1517/14728222.10.5.703 DOI Listing
October 2006