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Diana Bradford
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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) 31 (8): 1383–1389.
https://doi.org/10.1158/1078-0432.CCR-24-3439
Published: 14 April 2025
View articletitled, 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: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer

Michael I. Barbato, Diana Bradford, Yi Ren, Stephanie L. Aungst, Claudia P. Miller, Lili Pan, Jeanne F. Zirkelbach, Yangbing Li, Youwei Bi, Jianghong Fan, Manuela Grimstein, Sarah E. Dorff, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Barbara Scepura, Peter Schotland, Opeyemi Udoka, Idara Ojofeitimi, John K. Leighton, Nam A. Rahman, Richard Pazdur, Harpreet Singh, Paul G. Kluetz, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (16): 3364–3370.
https://doi.org/10.1158/1078-0432.CCR-24-0949
Published: 15 August 2024
View articletitled, FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
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Journal Articles

Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium

Jason Fangusaro, Robert A. Avery, Michael J. Fisher, Roger J. Packer, Karin S. Walsh, Antoinette Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G. Kluetz, Martha Donoghue, Elizabeth S. Duke
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (11): 2303–2308.
https://doi.org/10.1158/1078-0432.CCR-23-3386
Published: 03 June 2024
View articletitled, Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium
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Journal Articles

FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma

Michael I. Barbato, Jeannette Nashed, Diana Bradford, Yi Ren, Sachia Khasar, Claudia P. Miller, Banu S. Zolnik, Hong Zhao, Yangbing Li, Youwei Bi, Stacy S. Shord, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Barbara Scepura, Raniya A. Al-Matari, Richard Pazdur, Paul G. Kluetz, Martha Donoghue, Harpreet Singh, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (2): 263–268.
https://doi.org/10.1158/1078-0432.CCR-23-1503
Published: 17 January 2024
View articletitled, FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma
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Journal Articles

FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

Sonia Singh, Diana Bradford, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Lingshan Wang, Hong Zhao, Ye Xiong, Jiang Liu, Rosane Charlab, Jeffrey Kraft, Sachia Khasar, Claudia P. Miller, Donna R. Rivera, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (1): 23–28.
https://doi.org/10.1158/1078-0432.CCR-23-1270
Published: 05 January 2024
View articletitled, FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

Elizabeth S. Duke, Diana Bradford, Michelle Marcovitz, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Emily Nguyen, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Youwei Bi, Jeffrey Kraft, Sarah E. Dorff, Barbara Scepura, Maritsa Stephenson, Idara Ojofeitimi, Abhilasha Nair, Yu Han, Zivana Tezak, Steven J. Lemery, Richard Pazdur, Erin Larkins, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (18): 3573–3578.
https://doi.org/10.1158/1078-0432.CCR-23-0459
Published: 15 September 2023
View articletitled, FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors
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Journal Articles

FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors

Jaleh Fallah, Michael H. Brave, Chana Weinstock, Gautam U. Mehta, Diana Bradford, Haley Gittleman, Erik W. Bloomquist, Rosane Charlab, Salaheldin S. Hamed, Claudia P. Miller, Sarah E. Dorff, Wiley A. Chambers, Bronwyn D. Mixter, Jeannette Dinin, William F. Pierce, Tiffany K. Ricks, Shenghui Tang, Martha Donoghue, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (22): 4843–4848.
https://doi.org/10.1158/1078-0432.CCR-22-1054
Published: 14 November 2022
View articletitled, FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors
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Journal Articles

FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Janice Kim, Diana Bradford, Erin Larkins, Lee H. Pai-Scherf, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Emily Wearne, Whitney S. Helms, Amal Ayyoub, Youwei Bi, Jielin Sun, Rosane Charlab, Jiang Liu, Hong Zhao, Dun Liang, Soma Ghosh, Reena Philip, Richard Pazdur, Marc R. Theoret, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (20): 5452–5456.
https://doi.org/10.1158/1078-0432.CCR-21-0967
Published: 15 October 2021
View articletitled, FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

Diana Bradford, Erin Larkins, Sirisha L. Mushti, Lisa Rodriguez, Amy M. Skinner, Whitney S. Helms, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Jiang Liu, Rosane Charlab, Francisca Reyes Turcu, Dun Liang, Soma Ghosh, Donna Roscoe, Reena Philip, Autumn Zack-Taylor, Shenghui Tang, Paul G. Kluetz, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2130–2135.
https://doi.org/10.1158/1078-0432.CCR-20-3558
Published: 15 April 2021
View articletitled, FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions
Open the PDF for FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions in another window
Includes: Supplementary data