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Journal Articles

FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma

Sonia Singh, Diana Bradford, Somak Chatterjee, Xiaoxue Li, Stephanie L. Aungst, Amy M. Skinner, Claudia P. Miller, Sarah Kim-McOlash, Jeanne Fourie Zirkelbach, Ye Xiong, Youwei Bi, Ying-Hong Wang, Yuching Yang, Jielin Sun, Jeffrey Kraft, Rosane Charlab, Stacy S. Shord, Shenghui Tang, Barbara Scepura, Ilynn Bulatao, Opeyemi Udoka, Haleh Saber, Nam Atiqur. Rahman, Richard Pazdur, Harpreet Singh, Martha Donoghue, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2025)
https://doi.org/10.1158/1078-0432.CCR-24-3439
Published: 14 January 2025
View article titled, FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
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Includes: Supplementary data
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: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Hyon-Zu Lee, Virginia E. Kwitkowski, Pedro L. Del Valle, M. Stacey Ricci, Haleh Saber, Bahru A. Habtemariam, Julie Bullock, Erik Bloomquist, Yuan Li Shen, Xiao-Hong Chen, Janice Brown, Nitin Mehrotra, Sarah Dorff, Rosane Charlab, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (12): 2666–2670.
https://doi.org/10.1158/1078-0432.CCR-14-3119
Published: 14 June 2015
View article titled, FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
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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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Journal Articles

U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

R. Angelo de Claro, Karen McGinn, Virginia Kwitkowski, Julie Bullock, Aakanksha Khandelwal, Bahru Habtemariam, Yanli Ouyang, Haleh Saber, Kyung Lee, Kallappa Koti, Mark Rothmann, Marjorie Shapiro, Francisco Borrego, Kathleen Clouse, Xiao Hong Chen, Janice Brown, Lara Akinsanya, Robert Kane, Edvardas Kaminskas, Ann Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (21): 5845–5849.
https://doi.org/10.1158/1078-0432.CCR-12-1803
Published: 06 November 2012
View article titled, U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma
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Journal Articles

U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

Albert Deisseroth, Edvardas Kaminskas, Joseph Grillo, Wei Chen, Haleh Saber, Hong L. Lu, Mark D. Rothmann, Satjit Brar, Jian Wang, Christine Garnett, Julie Bullock, Laurie B. Burke, Atiqur Rahman, Rajeshwari Sridhara, Ann Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (12): 3212–3217.
https://doi.org/10.1158/1078-0432.CCR-12-0653
Published: 14 June 2012
View article titled, U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis
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Journal Articles

Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

Michael Brave, Vicki Goodman, Edvardas Kaminskas, Ann Farrell, William Timmer, Sarah Pope, Ravi Harapanhalli, Haleh Saber, David Morse, Julie Bullock, Angela Men, Carol Noory, Roshni Ramchandani, Leslie Kenna, Brian Booth, Joga Gobburu, Xiaoping Jiang, Rajeshwari Sridhara, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (2): 352–359.
https://doi.org/10.1158/1078-0432.CCR-07-4175
Published: 25 January 2008
View article titled, Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate
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Journal Articles

Sorafenib for the Treatment of Advanced Renal Cell Carcinoma

Robert C. Kane, Ann T. Farrell, Haleh Saber, Shenghui Tang, Gene Williams, Josephine M. Jee, Chengyi Liang, Brian Booth, Nallaperumal Chidambaram, David Morse, Rajeshwari Sridhara, Patricia Garvey, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (24): 7271–7278.
https://doi.org/10.1158/1078-0432.CCR-06-1249
Published: 22 December 2006
View article titled, Sorafenib for the Treatment of Advanced Renal Cell Carcinoma
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