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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 Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

Michael H. Brave, William F. Maguire, Chana Weinstock, Hui Zhang, Xin Gao, Fang Li, Jingyu Yu, Wentao Fu, Hong Zhao, William F. Pierce, Elaine Chang, Jeannette Dinin, Mallorie H. Fiero, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (21): 4815–4821.
https://doi.org/10.1158/1078-0432.CCR-24-1393
Published: 01 November 2024
View article titled, FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer

Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H. Fiero, Ankit Shah, Salaheldin S. Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K. Ricks, Rajan Pragani, Arulvathani Arudchandran, Paresma Patel, Shadia Zaman, Arpita Roy, Shyam Kalavar, Soma Ghosh, William F. Pierce, Nam Atiqur Rahman, Shenghui Tang, Bronwyn D. Mixter, Paul G. Kluetz, Richard Pazdur, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (19): 3835–3840.
https://doi.org/10.1158/1078-0432.CCR-23-0991
Published: 02 October 2023
View article titled, FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer
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Journal Articles

FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer

Elizabeth S. Duke, Amy K. Barone, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Emasenyie Isikwei, Hong Zhao, Youwei Bi, Jiang Liu, Nam Atiqur Rahman, Emily Wearne, John K. Leighton, Maritsa Stephenson, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (19): 4173–4177.
https://doi.org/10.1158/1078-0432.CCR-22-0873
Published: 03 October 2022
View article titled, FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer
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Journal Articles

FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC

Erica C. Nakajima, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yajun Liu, Hong Zhao, Youwei Bi, Jiang Liu, Atiqur Rahman, Emily Wearne, Idara Ojofeitimi, Lauren Tesh Hotaki, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (8): 1482–1486.
https://doi.org/10.1158/1078-0432.CCR-21-3074
Published: 14 April 2022
View article titled, FDA Approval Summary: Sotorasib for <em>KRAS G12C</em>-Mutated Metastatic NSCLC
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Journal Articles

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Sonia Singh, Adnan A. Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S. Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S. Helms, Xing Wang, Rajiv Agarwal, Rajan Pragani, Kwadwo Korsah, Shenghui Tang, John Leighton, Atiqur Rahman, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2378–2382.
https://doi.org/10.1158/1078-0432.CCR-20-3901
Published: 01 May 2021
View article titled, FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
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Includes: Supplementary data
Journal Articles

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group

R. Donald Harvey, Kathryn F. Mileham, Vishal Bhatnagar, Jamie R. Brewer, Atiqur Rahman, Cassadie Moravek, Andrew S. Kennedy, Elizabeth A. Ness, E. Claire Dees, S. Percy Ivy, Scot W. Ebbinghaus, Caroline Schenkel, Thomas S. Uldrick
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2400–2407.
https://doi.org/10.1158/1078-0432.CCR-20-3855
Published: 01 May 2021
View article titled, Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group
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Journal Articles

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer

Jennifer J. Gao, Christy L. Osgood, Yutao Gong, Hui Zhang, Erik W. Bloomquist, Xiling Jiang, Junshan Qiu, Jingyu Yu, Pengfei Song, Nam Atiqur Rahman, Haw-Jyh Chiu, Tiffany K. Ricks, Fatima Rizvi, Sherry Hou, Willie Wilson, Abde M. Abukhdeir, Jeffrey Seidman, Soma Ghosh, Reena Philip, William F. Pierce, Vishal Bhatnagar, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2126–2129.
https://doi.org/10.1158/1078-0432.CCR-20-3474
Published: 15 April 2021
View article titled, FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer
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Journal Articles

Lessons Learned: Dose Selection of Small Molecule–Targeted Oncology Drugs

Julie M. Bullock, Atiqur Rahman, Qi Liu
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (11): 2630–2638.
https://doi.org/10.1158/1078-0432.CCR-15-2646
Published: 31 May 2016
View article titled, Lessons Learned: Dose Selection of Small Molecule–Targeted Oncology Drugs
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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

Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes

Edvardas Kaminskas, Ann Farrell, Sophia Abraham, Amy Baird, Li-Shan Hsieh, Shwu-Luan Lee, John K. Leighton, Hasmukh Patel, Atiqur Rahman, Rajeshwara Sridhara, Yong-Cheng Wang, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (10): 3604–3608.
https://doi.org/10.1158/1078-0432.CCR-04-2135
Published: 16 May 2005
View article titled, Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes
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Journal Articles

Pemetrexed in Malignant Pleural Mesothelioma

Maitreyee Hazarika, Robert M. White, Jr., Brian P. Booth, Yong-Cheng Wang, Doo Y. Lee Ham, Cheng Yi Liang, Atiqur Rahman, Jogarao V.S. Gobburu, Ning Li, Rajeshwari Sridhara, David E. Morse, Richard Lostritto, Patricia Garvey, John R. Johnson, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (3): 982–992.
https://doi.org/10.1158/1078-0432.982.11.3
Published: 11 February 2005
View article titled, Pemetrexed in Malignant Pleural Mesothelioma
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Journal Articles

Approval Summary: Docetaxel in Combination with Prednisone for the Treatment of Androgen-Independent Hormone-Refractory Prostate Cancer

Ramzi Dagher, Ning Li, Sophia Abraham, Atiqur Rahman, Raji Sridhara, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2004) 10 (24): 8147–8151.
https://doi.org/10.1158/1078-0432.CCR-04-1402
Published: 28 December 2004
View article titled, Approval Summary: <subtitle>Docetaxel in Combination with Prednisone for the Treatment of Androgen-Independent Hormone-Refractory Prostate Cancer</subtitle>
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Journal Articles

Approval Summary for Bortezomib for Injection in the Treatment of Multiple Myeloma

Peter F. Bross, Robert Kane, Ann T. Farrell, Sophia Abraham, Kimberly Benson, Margaret E. Brower, Sean Bradley, Jogarao V. Gobburu, Anwar Goheer, Shwu-Luan Lee, John Leighton, Cheng Yi Liang, Richard T. Lostritto, William D. McGuinn, David E. Morse, Atiqur Rahman, Lilliam A. Rosario, S. Leigh Verbois, Grant Williams, Yong-Cheng Wang, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2004) 10 (12): 3954–3964.
https://doi.org/10.1158/1078-0432.CCR-03-0781
Published: 24 June 2004
View article titled, Approval Summary for Bortezomib for Injection in the Treatment of Multiple Myeloma
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Journal Articles

United States Food and Drug Administration Drug Approval Summary: Gefitinib (ZD1839; Iressa) Tablets

Martin H. Cohen, Grant A. Williams, Rajeshwari Sridhara, Gang Chen, W. David McGuinn, Jr., David Morse, Sophia Abraham, Atiqur Rahman, Chenyi Liang, Richard Lostritto, Amy Baird, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2004) 10 (4): 1212–1218.
https://doi.org/10.1158/1078-0432.CCR-03-0564
Published: 20 February 2004
View article titled, United States Food and Drug Administration Drug Approval Summary: <subtitle>Gefitinib (ZD1839; Iressa) Tablets</subtitle>
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Journal Articles

Fulvestrant in Postmenopausal Women with Advanced Breast Cancer

Peter F. Bross, Amy Baird, Gang Chen, Josephine M. Jee, Richard T. Lostritto, David E. Morse, Liliam A. Rosario, Gene M. Williams, Peiling Yang, Atiqur Rahman, Grant Williams, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2003) 9 (12): 4309–4317.
Published: 10 October 2003
View article titled, Fulvestrant in Postmenopausal Women with Advanced Breast Cancer
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Journal Articles

Approval Summary for Zoledronic Acid for Treatment of Multiple Myeloma and Cancer Bone Metastases

Amna Ibrahim, Nancy Scher, Grant Williams, Rajeshwari Sridhara, Ning Li, Gang Chen, John Leighton, Brian Booth, Jogarao V. S. Gobburu, Atiqur Rahman, Yung Hsieh, Rebecca Wood, Debra Vause, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2003) 9 (7): 2394–2399.
Published: 01 July 2003
View article titled, Approval Summary for Zoledronic Acid for Treatment of Multiple Myeloma and Cancer Bone Metastases
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Journal Articles

Approval Summary: Imatinib Mesylate Capsules for Treatment of Adult Patients with Newly Diagnosed Philadelphia Chromosome-positive Chronic Myelogenous Leukemia in Chronic Phase

John R. Johnson, Peter Bross, Martin Cohen, Mark Rothmann, Gang Chen, Anne Zajicek, Joga Gobburu, Atiqur Rahman, Ann Staten, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2003) 9 (6): 1972–1979.
Published: 01 June 2003
View article titled, Approval Summary: <subtitle>Imatinib Mesylate Capsules for Treatment of Adult Patients with Newly Diagnosed Philadelphia Chromosome-positive Chronic Myelogenous Leukemia in Chronic Phase</subtitle>
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Journal Articles

Approval Summary: Imatinib Mesylate in the Treatment of Metastatic and/or Unresectable Malignant Gastrointestinal Stromal Tumors

Ramzi Dagher, Martin Cohen, Gene Williams, Mark Rothmann, Jogarao Gobburu, Gabriel Robbie, Atiqur Rahman, Gang Chen, Ann Staten, Donna Griebel, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2002) 8 (10): 3034–3038.
Published: 01 October 2002
View article titled, Approval Summary: <subtitle>Imatinib Mesylate in the Treatment of Metastatic and/or Unresectable Malignant Gastrointestinal Stromal Tumors</subtitle>
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Journal Articles

Approval Summary for Imatinib Mesylate Capsules in the Treatment of Chronic Myelogenous Leukemia

Martin H. Cohen, Grant Williams, John R. Johnson, John Duan, Jogarao Gobburu, Atiqur Rahman, Kimberly Benson, John Leighton, Sung K. Kim, Rebecca Wood, Mark Rothmann, Gang Chen, Khin Maung U, Ann M. Staten, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2002) 8 (5): 935–942.
Published: 01 May 2002
View article titled, Approval Summary for Imatinib Mesylate Capsules in the Treatment of Chronic Myelogenous Leukemia
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