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Amy E. McKee
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Journal Articles

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
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (6): 1702–1708.
https://doi.org/10.1158/1078-0432.CCR-18-2743
Published: 15 March 2019
View article titled, FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma
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Journal Articles

FDA's Approval of the First Biosimilar to Bevacizumab

Sandra J. Casak, Steven J. Lemery, Jee Chung, Chana Fuchs, Sarah J. Schrieber, Edwin C.Y. Chow, Weishi Yuan, Lisa Rodriguez, Thomas Gwise, Anne Rowzee, Sue Lim, Patricia Keegan, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (18): 4365–4370.
https://doi.org/10.1158/1078-0432.CCR-18-0566
Published: 14 September 2018
View article titled, FDA's Approval of the First Biosimilar to Bevacizumab
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Journal Articles

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma

Julia A. Beaver, Marc R. Theoret, Sirisha Mushti, Kun He, Meredith Libeg, Kirsten Goldberg, Rajeshwari Sridhara, Amy E. McKee, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (14): 3479–3483.
https://doi.org/10.1158/1078-0432.CCR-16-0714
Published: 13 July 2017
View article titled, FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAF<sup>V600</sup> Wild-Type Unresectable or Metastatic Melanoma
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Journal Articles

FDA's Approach to Regulating Biosimilars

Steven J. Lemery, M. Stacey Ricci, Patricia Keegan, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (8): 1882–1885.
https://doi.org/10.1158/1078-0432.CCR-16-1354
Published: 13 April 2017
View article titled, FDA's Approach to Regulating Biosimilars
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Journal Articles

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Julia A. Beaver, Abraham Tzou, Gideon M. Blumenthal, Amy E. McKee, Geoffrey Kim, Richard Pazdur, Reena Philip
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (6): 1368–1372.
https://doi.org/10.1158/1078-0432.CCR-16-1098
Published: 14 March 2017
View article titled, An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies
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Includes: Supplementary data
Journal Articles

U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma

Harpreet Singh, Michael Brave, Julia A. Beaver, Joyce Cheng, Shenghui Tang, Eias Zahalka, Todd R. Palmby, Rajesh Venugopal, Pengfei Song, Qi Liu, Chao Liu, Jingyu Yu, Xiao Hong Chen, Xing Wang, Yaning Wang, Paul G. Kluetz, Selena R. Daniels, Elektra J. Papadopoulos, Rajeshwari Sridhara, Amy E. McKee, Amna Ibrahim, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (2): 330–335.
https://doi.org/10.1158/1078-0432.CCR-16-1073
Published: 15 January 2017
View article titled, U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma
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Journal Articles

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib

Erin Larkins, Gideon M. Blumenthal, Huanyu Chen, Kun He, Rajiv Agarwal, Gerlie Gieser, Olen Stephens, Eias Zahalka, Kimberly Ringgold, Whitney Helms, Stacy Shord, Jingyu Yu, Hong Zhao, Gina Davis, Amy E. McKee, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (21): 5171–5176.
https://doi.org/10.1158/1078-0432.CCR-16-1293
Published: 31 October 2016
View article titled, FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib
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Journal Articles

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, Shengui Tang, Rajeshwari Sridhara, Wei Chen, Todd R. Palmby, Jeanne Fourie Zirkelbach, Wentao Fu, Qi Liu, Amy Tilley, Geoffrey Kim, Paul G. Kluetz, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (20): 4968–4972.
https://doi.org/10.1158/1078-0432.CCR-16-0493
Published: 13 October 2016
View article titled, FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
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Journal Articles

FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs

Gwynn Ison, Julia A. Beaver, W. David McGuinn, Jr, Todd R. Palmby, Jeannette Dinin, Rosane Charlab, Anshu Marathe, Runyan Jin, Qi Liu, Xiao Hong Chen, Xavier Ysern, Olen Stephens, Ge Bai, Yaning Wang, Sarah E. Dorff, Joyce Cheng, Shenghui Tang, Rajeshwari Sridhara, William Pierce, Amy E. McKee, Amna Ibrahim, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (18): 4545–4549.
https://doi.org/10.1158/1078-0432.CCR-16-0638
Published: 15 September 2016
View article titled, FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs
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Journal Articles

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

Pasi A. Jänne, Geoffrey Kim, Alice T. Shaw, Rajeshwari Sridhara, Richard Pazdur, Amy E. McKee
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (11): 2613–2617.
https://doi.org/10.1158/1078-0432.CCR-15-2643
Published: 31 May 2016
View article titled, Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle
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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

Geoffrey Kim, Gwynn Ison, Amy E. McKee, Hui Zhang, Shenghui Tang, Thomas Gwise, Rajeshwari Sridhara, Eunice Lee, Abraham Tzou, Reena Philip, Haw-Jyh Chiu, Tiffany K. Ricks, Todd Palmby, Anne Marie Russell, Gaetan Ladouceur, Elimika Pfuma, Hongshan Li, Liang Zhao, Qi Liu, Rajesh Venugopal, Amna Ibrahim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (19): 4257–4261.
https://doi.org/10.1158/1078-0432.CCR-15-0887
Published: 30 September 2015
View article titled, FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline <em>BRCA</em>-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
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Journal Articles

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation

Geoffrey Kim, Amy E. McKee, Yang-Min Ning, Maitreyee Hazarika, Marc Theoret, John R. Johnson, Qiang Casey Xu, Shenghui Tang, Rajeshwari Sridhara, Xiaoping Jiang, Kun He, Donna Roscoe, W. David McGuinn, Whitney S. Helms, Anne Marie Russell, Sarah Pope Miksinski, Jeanne Fourie Zirkelbach, Justin Earp, Qi Liu, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (19): 4994–5000.
https://doi.org/10.1158/1078-0432.CCR-14-0776
Published: 30 September 2014
View article titled, FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAF<sup>V600E</sup> Mutation
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Journal Articles

On Trk—The TrkB Signal Transduction Pathway Is an Increasingly Important Target in Cancer Biology

Carol J. Thiele, Zhijie Li, Amy E. McKee
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (19): 5962–5967.
https://doi.org/10.1158/1078-0432.CCR-08-0651
Published: 30 September 2009
View article titled, On <em>Trk</em>—The TrkB Signal Transduction Pathway Is an Increasingly Important Target in Cancer Biology
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