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Julia A. Beaver
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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 article titled, FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Katie Chon, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Stephanie Aungst, Emily Wearne, Sriram Subramaniam, Yangbing Li, Jiang Liu, Jielin Sun, Rosane Charlab, Hong Zhao, Banu Saritas-Yildirim, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (17): 3262–3266.
https://doi.org/10.1158/1078-0432.CCR-22-3713
Published: 01 September 2023
View article titled, FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with <em>EGFR</em> Exon 20 Insertion Mutations
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC

Luckson N. Mathieu, Erin Larkins, Arup K. Sinha, Pallavi S. Mishra-Kalyani, Samina Jafri, Shyam Kalavar, Soma Ghosh, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (16): 2973–2978.
https://doi.org/10.1158/1078-0432.CCR-22-3699
Published: 15 August 2023
View article titled, FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC
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Journal Articles

FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Elizabeth S. Duke, Liza Stapleford, Nicole Drezner, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Kimberly Maxfield, Jeanne Fourie Zirkelbach, Youwei Bi, Jiang Liu, Xinyuan Zhang, Hezhen Wang, Yuching Yang, Nan Zheng, Kelie Reece, Emily Wearne, Jacqueline J. Glen, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (3): 508–512.
https://doi.org/10.1158/1078-0432.CCR-22-2072
Published: 01 February 2023
View article titled, FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with <em>EGFR</em> Exon 20 Insertion Mutations
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Journal Articles

FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer

Mirat Shah, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, William F. Pierce, Abhilasha Nair, Jonathan Herz, Kim J. Robertson, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (24): 5249–5253.
https://doi.org/10.1158/1078-0432.CCR-22-1110
Published: 15 December 2022
View article titled, FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer
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Journal Articles

FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease

M. Naomi Horiba, Sandra J. Casak, Pallavi S. Mishra-Kalyani, Pourab Roy, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (24): 5244–5248.
https://doi.org/10.1158/1078-0432.CCR-22-0617
Published: 15 December 2022
View article titled, FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease
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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 article titled, FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors
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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: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

Sandra J. Casak, Shan Pradhan, Lola A. Fashoyin-Aje, Yi Ren, Yuan-Li Shen, Yuan Xu, Edwin Chiu Yuen Chow, Ye Xiong, Jeanne Fourie Zirklelbach, Jiang Liu, Rosane Charlab, William F. Pierce, Nataliya Fesenko, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (13): 2733–2737.
https://doi.org/10.1158/1078-0432.CCR-21-4462
Published: 01 July 2022
View article titled, FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation
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Journal Articles

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC

Oladimeji Akinboro, Erin Larkins, Lee H. Pai-Scherf, Luckson N. Mathieu, Yi Ren, Joyce Cheng, Mallorie H. Fiero, Wentao Fu, Youwei Bi, Shyam Kalavar, Samina Jafri, Pallavi S. Mishra-Kalyani, Jeanne Fourie Zirkelbach, Hongshan Li, Hong Zhao, Kun He, Whitney S. Helms, Meredith K. Chuk, Min Wang, Ilynn Bulatao, Jonathan Herz, Blaire L. Osborn, Yuan Xu, Jiang Liu, Yutao Gong, Sharon Sickafuse, Rebecca Cohen, Martha Donoghue, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (11): 2221–2228.
https://doi.org/10.1158/1078-0432.CCR-21-3844
Published: 01 June 2022
View article titled, FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC
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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: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer

Melanie Royce, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, C.J. George Chang, Tiffany K. Ricks, Krithika A. Shetty, Jeffrey Kraft, Junshan Qiu, Pengfei Song, Rosane Charlab, Jingyu Yu, Kathryn E. King, Anshu Rastogi, Brian Janelsins, Wendy C. Weinberg, Kathleen Clouse, Vicky Borders-Hemphill, Lindsey Brown, Candace Gomez-Broughton, Zhong Li, Thuy Thanh Nguyen, Zhihao Qiu, Anh-Thy Ly, Suyoung Chang, Tingting Gao, Chi-Ming Tu, Bellinda King-Kallimanis, William F. Pierce, Kelly Chiang, Clara Lee, Kirsten B. Goldberg, John K. Leighton, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (8): 1487–1492.
https://doi.org/10.1158/1078-0432.CCR-21-3247
Published: 14 April 2022
View article titled, FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer
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Journal Articles

U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review

Shaily Arora, Preeti Narayan, Christy L. Osgood, Suparna Wedam, Tatiana M. Prowell, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Soma Ghosh, Reena Philip, Gwynn Ison, Tara Berman, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (6): 1072–1086.
https://doi.org/10.1158/1078-0432.CCR-21-2600
Published: 15 March 2022
View article titled, U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review
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Journal Articles

U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review

Shaily Arora, Preeti Narayan, Gwynn Ison, Tara Berman, Daniel L. Suzman, Suparna Wedam, Tatiana M. Prowell, Soma Ghosh, Reena Philip, Christy L. Osgood, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (6): 1058–1071.
https://doi.org/10.1158/1078-0432.CCR-21-2599
Published: 15 March 2022
View article titled, U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review
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Journal Articles

FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma

Elaine Chang, Chana Weinstock, Lijun Zhang, Mallorie H. Fiero, Miao Zhao, Eias Zahalka, Tiffany K. Ricks, Jeanne Fourie Zirkelbach, Junshan Qiu, Jingyu Yu, Xiao Hong Chen, Vishal Bhatnagar, Kirsten B. Goldberg, Shenghui Tang, Paul G. Kluetz, Richard Pazdur, Amna Ibrahim, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (3): 441–445.
https://doi.org/10.1158/1078-0432.CCR-21-2334
Published: 01 February 2022
View article titled, FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma
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Journal Articles

FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma

Erica C. Nakajima, Paz J. Vellanki, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Youwei Bi, Hisham Qosa, Jiang Liu, Hong Zhao, Missiratch Biable, Lauren Tesh Hotaki, Yuan-Li Shen, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (3): 446–451.
https://doi.org/10.1158/1078-0432.CCR-21-1466
Published: 01 February 2022
View article titled, FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma
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Journal Articles

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Luckson N. Mathieu, Erin Larkins, Oladimeji Akinboro, Pourab Roy, Anup K. Amatya, Mallorie H. Fiero, Pallavi S. Mishra-Kalyani, Whitney S. Helms, Claire E. Myers, Amy M. Skinner, Stephanie Aungst, Runyan Jin, Hong Zhao, Huiming Xia, Jeanne Fourie Zirkelbach, Youwei Bi, Yangbing Li, Jiang Liu, Manuela Grimstein, Xinyuan Zhang, Stacie Woods, Kelie Reece, Abdelrahmman M. Abukhdeir, Soma Ghosh, Reena Philip, Shenghui Tang, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (2): 249–254.
https://doi.org/10.1158/1078-0432.CCR-21-1566
Published: 19 January 2022
View article titled, FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
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Journal Articles

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Abigail L. Koch, Paz J. Vellanki, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yuan Li Shen, Huiming Xia, Yangbing Li, Jiang Liu, Jeanne Fourie Zirkelbach, Elitza Palazov, Aleksandr Gamarian, Qiuyi Choo, Arūnas Girčys, Ulrich-Peter Rohr, Nataliya Fesenko, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (24): 6638–6643.
https://doi.org/10.1158/1078-0432.CCR-21-1034
Published: 15 December 2021
View article titled, FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review
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Includes: Supplementary data
Journal Articles

Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Anup K. Amatya, Mallorie H. Fiero, Erik W. Bloomquist, Arup K. Sinha, Steven J. Lemery, Harpreet Singh, Amna Ibrahim, Martha Donoghue, Lola A. Fashoyin-Aje, R. Angelo de Claro, Nicole J. Gormley, Laleh Amiri-Kordestani, Rajeshwari Sridhara, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Shenghui Tang
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (21): 5753–5756.
https://doi.org/10.1158/1078-0432.CCR-20-4912
Published: 01 November 2021
View article titled, Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
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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 article titled, FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With <em>RET</em> Gene Mutations or Fusions
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Includes: Supplementary data