AmyElizabethMcKeeMD

PubMed

• 25 citations
  Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities
  Amy Barone, Denise Casey, Amy E. McKee, Gregory H. Reaman> ;Pediatric Blood & Cancer. 2019 Aug 1
• 1 citations
  Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology
  Rene Bruno, Jin Y. Jin, Kimberly Maxfield, Lauren Milligan, Chao Liu, Yaning Wang, Amy E. McKee, Issam Zineh> ;Clinical Pharmacology and Therapeutics. 2019 Jul 1
• 1 citations
  U.S. Food and Drug Administration Benefit‐Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained...
  E. Dianne Pulte, Tanya Wroblewski, Erik Bloomquist, Shenghui Tang, Ann T. Farrell, Albert Deisseroth, Amy E. McKee, Richard Pazdur> ;The Oncologist. 2019 May 1
• 122 citations
  FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy
  Daniel L. Suzman, Sundeep Agrawal, Yang Min Ning, V. Ellen Maher, Laura L. Fernandes, Stella W. Karuri, Shenghui Tang, Rajeshwari Sridhara, Jason Schroeder, Kirsten B....> ;The Oncologist. 2019 Apr 1
• 140 citations
  FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma
  Najat Bouchkouj, Yvette L. Kasamon, R. Angelo de Claro, Bindu George, Xue Lin, Shiowjen Lee, Gideon M. Blumenthal, Wilson Bryan, Amy E. McKee, Richard Pazdur> ;Clinical Cancer Research. 2019 Mar 15
• 142 citations
  FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1
  Lola Fashoyin-Aje, Martha Donoghue, Huanyu Chen, Kun He, Janaki Veeraraghavan, Kirsten B. Goldberg, Patricia Keegan, Amy E. McKee, Richard Pazdur> ;The Oncologist. 2019 Jan 1
• 36 citations
  FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation.
  Patricia A. Oneal, Virginia E. Kwitkowski, Lola Luo, Yuan Li Shen, Sriram Subramaniam, Stacy S. Shord, Kirsten B. Goldberg, Amy E. McKee, Edvardas Kaminskas, Ann T. Fa...> ;The Oncologist. 2018 Dec 1
• 27 citations
  FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis
  Yvette L. Kasamon, Chia-Wen Ko, Sriram Subramaniam, Lian Ma, Yuching Yang, Lei Nie, Stacy S. Shord, Donna Przepiorka, Ann T. Farrell, Amy E. McKee, Richard Pazdur> ;The Oncologist. 2018 Dec 1
• 32 citations
  FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia.
  E. Dianne Pulte, Jonathon Vallejo, Donna Przepiorka, Lei Nie, Ann T. Farrell, Kirsten B. Goldberg, Amy E. McKee, Richard Pazdur> ;The Oncologist. 2018 Nov 1
• 22 citations
  FDA's Approval of the First Biosimilar to Bevacizumab.
  Sandra J. Casak, Steven Lemery, Jee Chung, Chana Fuchs, Sarah J Schrieber, Edwin C. Y. Chow, Weishi Yuan, Lisa Rodriguez, Thomas Gwise, Anne M. Rowzee, Sue Lim, Patric...> ;Clinical Cancer Research. 2018 Sep 15
• 33 citations
  FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
  Elizabeth Dianne Pulte, Andrew Dmytrijuk, Lei Nie, Kirsten B. Goldberg, Amy E. McKee, Ann T. Farrell, Richard Pazdur> ;The Oncologist. 2018 Jun 1
• 132 citations
  FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations
  Lauretta Odogwu, Luckson Mathieu, Gideon M. Blumenthal, Erin Larkins, Kirsten B. Goldberg, Norma Griffin, Karen Bijwaard, Eunice Y. Lee, Reena Philip, Xiaoping Jiang, ...> ;The Oncologist. 2018 Jun 1
• 16 citations
  Complexity of Delivering Precision Medicine: Opportunities and Challenges.
  Andrew M. Davis, Amy E. McKee, Warren A. Kibbe, Victoria M. Villaflor> ;American Society of Clinical Oncology Educational Book. American Society of Clinical Oncology. Annual Meeting. 2018 May 23
• 5 citations
  Breakthrough-Therapy Designation — An FDA Perspective
  Jacqueline Corrigan-Curay, Amy E. McKee, Peter Stein> ;The New England Journal of Medicine. 2018 Apr 11
• 11 citations
  Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib
  Lorraine Pelosof, Steven Lemery, Sandra Casak, Xiaoping Jiang, Lisa Rodriguez, Vadryn Pierre, Youwei Bi, Jiang Liu, Jeanne Fourie Zirkelbach, Anuja Patel, Kirsten B. G...> ;The Oncologist. 2018 Apr 1
• 13 citations
  US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments
  Suparna Wedam, Julia A. Beaver, Laleh Amiri-Kordestani, Erik Bloomquist, Shenghui Tang, Kirsten B. Goldberg, Rajeshwari Sridhara, Amna Ibrahim, Geoffrey Kim, Paul G. K...> ;Journal of Clinical Oncology. 2018 Mar 9
• 45 citations
  FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation
  Lauretta Odogwu, Luckson Mathieu, Kirsten B. Goldberg, Gideon M. Blumenthal, Erin Larkins, Mallorie H. Fiero, Lisa Rodriguez, Karen Bijwaard, Eunice Y. Lee, Reena Phil...> ;The Oncologist. 2018 Mar 1
• 91 citations
  FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
  Amanda J. Walker, Suparna Wedam, Laleh Amiri-Kordestani, Erik Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Wei Chen, Todd R. Palmby, Jeanne Fourie Zirkelbach, Wenta...> ;Clinical Cancer Research. 2016 Oct 15
• 24 citations
  The FDA Oncology Center of Excellence and precision medicine
  Kirsten B. Goldberg, Gideon M. Blumenthal, Amy E. McKee, Richard Pazdur> ;Experimental Biology and Medicine. 2018 Feb 1
• 18 citations
  Survival of ethnic and racial minority patients with multiple myeloma treated with newer medications.
  E. Dianne Pulte, Lei Nie, Nicole J. Gormley, Kirsten B. Goldberg, Amy E. McKee, Ann T. Farrell, Richard Pazdur> ;Blood Advances. 2018 Jan 23
• 2 citations
  Report on the Third FDA–AACR Oncology Dose-Finding Workshop
  Leisha A. Emens, Rene Bruno, Eric H. Rubin, Elizabeth M. Jaffee, Amy E. McKee> ;Cancer Immunology Research. 2017 Dec 1
• 200 citations
  FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond
  Lee Pai-Scherf, Gideon M. Blumenthal, Hongshan Li, Sriram Subramaniam, Pallavi S. Mishra-Kalyani, Kun He, Hong Zhao, Jingyu Yu, Mark Paciga, Kirsten B. Goldberg, Amy E...> ;The Oncologist. 2017 Nov 1
• 54 citations
  FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy
  Vishal Bhatnagar, Nicole J. Gormley, Lola Luo, Yuan Li Shen, Rajeshwari Sridhara, Sriram Subramaniam, Guoxiang Shen, Lian Ma, Stacy S. Shord, Kirsten B. Goldberg, Ann ...> ;The Oncologist. 2017 Nov 1
• 35 citations
  FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper.
  Thomas J. Herzog, Gwynn Ison, Ronald D. Alvarez, Sanjeeve Balasubramaniam, Deborah K. Armstrong, Julia A. Beaver, Annie Ellis, Shenghui Tang, Peg Ford, Amy E. McKee, D...> ;Gynecologic Oncology. 2017 Oct 1
• 25 citations
  How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?
  Amy E. McKee, André O. Markon, Kirk M Chan-Tack, Peter Lurie> ;Journal of Clinical Pharmacology. 2017 Sep 15
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Journal Articles

• FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.  
  Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Li..., Clin Cancer Res, 2015
• NCCN Working Group report: designing clinical trials in the era of multiple biomarkers and targeted therapies.  
  Venook AP, Arcila ME, Benson AB 3rd, Berry DA, Camidge DR, Carlson RW, Choueiri TK, Guild V, Kalemkerian GP, Kurzrock R, Lovly CM, McKee AE, Morgan RJ, Olszanski AJ, R..., J Natl Compr Canc Netw, 2014
• PKC-mediated survival signaling in breast carcinoma cells: a role for MEK1-AP1 signaling.  
  Weldon CB, McKee A, Collins-Burow BM, Melnik LI, Scandurro AB, McLachlan JA, Burow ME, Beckman BS., Int J Oncol, 2005
• Cross-talk between phosphatidylinositol-3 kinase and sphingomyelinase pathways as a mechanism for cell survival/death decisions  
  Burow ME, Weldon CB, Collins-Burow BM, Ramsey N, McKee A, Klippel A, McLachlan JA, Clejan S, Beckman BS., J Biol Chem, 2000
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Abstracts/Posters

• Unlike Other Cancers, Neuroblastoma Contains a High Frequency of Tumor-initiating Cells with Stem Cell-Like Behavior.
  Amy E. McKee, Loen M. Hansford, David Venzon, David R. Kaplan, Carol J. Thiele., Advances in Neuroblastoma Research Meeting, 2008
• BDNF/TrkB pathway upregulates PTHrP in neuroblastoma.
  Amy E. McKee, Kelly Martin, Ana Markovic, Braden T. Greer, Jun S. Wei, Qing R. Chen, Javed Khan, and Carol J. Thiele., American Association of Cancer Research Annual Meeting, 2006
• PTHrP, a Mediator of Bone Metastasis, Is a Target of TrkB but Not TrkA in Neuroblastoma.
  Amy E McKee, Kelly Martin, Katsuya Nakamura, Braden Greer, Jun Wei, Javed Khan, Carol J Thiele., Advances in Neuroblastoma Research, 2006
• AP-1 transcriptional activation in MCF-7 breast carcinoma cells is dependent on intact PKC/MAPK.
  McKee A, Burrow ME, Scandurro AB, Beckman BS., American Association of Cancer Research Annual Meeting, 1999
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Lectures

• Regulatory Science: The Challenges with "SMALL DATA": Small Trials, Off-Label Use, and Single Patient INDs—Are We Doing Enough? 
  2018 ASCO Annual Meeting - Chicago, Illinois - 06/3/2018