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Journal Articles

FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome

Yvette L. Kasamon, Haiyan Chen, R. Angelo de Claro, Lei Nie, Jingjing Ye, Gideon M. Blumenthal, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (24): 7275–7280.
https://doi.org/10.1158/1078-0432.CCR-19-2030
Published: 13 December 2019
View article titled, FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
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Includes: Supplementary data
Journal Articles

Accuracy, Safety, and Reliability of Novel Phase I Designs—Response

Heng Zhou, Ying Yuan, Lei Nie
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (21): 5483–5484.
https://doi.org/10.1158/1078-0432.CCR-18-2677
Published: 01 November 2018
View article titled, Accuracy, Safety, and Reliability of Novel Phase I Designs—Response
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Journal Articles

Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials

Ying Yuan, Ruitao Lin, Daniel Li, Lei Nie, Katherine E. Warren
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (20): 4921–4930.
https://doi.org/10.1158/1078-0432.CCR-18-0246
Published: 15 October 2018
View article titled, Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials
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Includes: Supplementary data
Journal Articles

Accuracy, Safety, and Reliability of Novel Phase I Trial Designs

Heng Zhou, Ying Yuan, Lei Nie
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (18): 4357–4364.
https://doi.org/10.1158/1078-0432.CCR-18-0168
Published: 14 September 2018
View article titled, Accuracy, Safety, and Reliability of Novel Phase I Trial Designs
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Includes: Supplementary data
Journal Articles

FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia

Emily Y. Jen, Chia-Wen Ko, Jee Eun Lee, Pedro L. Del Valle, Antonina Aydanian, Charles Jewell, Kelly J. Norsworthy, Donna Przepiorka, Lei Nie, Jiang Liu, Christopher M. Sheth, Marjorie Shapiro, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (14): 3242–3246.
https://doi.org/10.1158/1078-0432.CCR-17-3179
Published: 15 July 2018
View article titled, FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia
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Includes: Supplementary data
Journal Articles

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Nicole J. Gormley, Chia-Wen Ko, Albert Deisseroth, Lei Nie, Edvardas Kaminskas, Natasha Kormanik, Kirsten B. Goldberg, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (22): 6759–6763.
https://doi.org/10.1158/1078-0432.CCR-16-2870
Published: 14 November 2017
View article titled, FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
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Journal Articles

Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Lei Nie, Eric H. Rubin, Nitin Mehrotra, José Pinheiro, Laura L. Fernandes, Amit Roy, Stuart Bailey, Dinesh P. de Alwis
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (11): 2623–2629.
https://doi.org/10.1158/1078-0432.CCR-15-2644
Published: 31 May 2016
View article titled, Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy
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Journal Articles

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia

R. Angelo de Claro, Karen M. McGinn, Nicole Verdun, Shwu-Luan Lee, Haw-Jyh Chiu, Haleh Saber, Margaret E. Brower, C.J. George Chang, Elimika Pfuma, Bahru Habtemariam, Julie Bullock, Yun Wang, Lei Nie, Xiao-Hong Chen, Donghao (Robert) Lu, Ali Al-Hakim, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (16): 3586–3590.
https://doi.org/10.1158/1078-0432.CCR-14-2225
Published: 13 August 2015
View article titled, FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia
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Journal Articles

FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma

Barry W. Miller, Donna Przepiorka, R. Angelo de Claro, Kyung Lee, Lei Nie, Natalie Simpson, Ramadevi Gudi, Haleh Saber, Stacy Shord, Julie Bullock, Dhananjay Marathe, Nitin Mehrotra, Li Shan Hsieh, Debasis Ghosh, Janice Brown, Robert C. Kane, Robert Justice, Edvardas Kaminskas, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (7): 1525–1529.
https://doi.org/10.1158/1078-0432.CCR-14-2522
Published: 31 March 2015
View article titled, FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma
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Includes: Supplementary data
Journal Articles

FDA Approval: Siltuximab for the Treatment of Patients with Multicentric Castleman Disease

Albert Deisseroth, Chia-Wen Ko, Lei Nie, Jeanne F. Zirkelbach, Liang Zhao, Julie Bullock, Nitin Mehrotra, Pedro Del Valle, Haleh Saber, Christopher Sheth, Brenda Gehrke, Robert Justice, Ann Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (5): 950–954.
https://doi.org/10.1158/1078-0432.CCR-14-1678
Published: 01 March 2015
View article titled, FDA Approval: Siltuximab for the Treatment of Patients with Multicentric Castleman Disease
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Journal Articles

U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia

Hyon-Zu Lee, Barry W. Miller, Virginia E. Kwitkowski, Stacey Ricci, Pedro DelValle, Haleh Saber, Joseph Grillo, Julie Bullock, Jeffry Florian, Nitin Mehrotra, Chia-Wen Ko, Lei Nie, Marjorie Shapiro, Mate Tolnay, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (15): 3902–3907.
https://doi.org/10.1158/1078-0432.CCR-14-0516
Published: 31 July 2014
View article titled, U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia
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