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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

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

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

Clin Cancer Res (2023) 29 (17): 3262–3266.

https://doi.org/10.1158/1078-0432.CCR-22-3713

Published: 01 September 2023

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

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

Clin Cancer Res (2023) 29 (16): 2973–2978.

https://doi.org/10.1158/1078-0432.CCR-22-3699

Published: 15 August 2023

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

Journal Articles

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

Clin Cancer Res (2023) 29 (3): 508–512.

https://doi.org/10.1158/1078-0432.CCR-22-2072

Published: 01 February 2023

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

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

Clin Cancer Res (2022) 28 (24): 5249–5253.

https://doi.org/10.1158/1078-0432.CCR-22-1110

Published: 15 December 2022

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

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

Clin Cancer Res (2022) 28 (24): 5244–5248.

https://doi.org/10.1158/1078-0432.CCR-22-0617

Published: 15 December 2022

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

Journal Articles

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

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

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

Clin Cancer Res (2022) 28 (19): 4173–4177.

https://doi.org/10.1158/1078-0432.CCR-22-0873

Published: 03 October 2022

View articletitled, FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer

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

Clin Cancer Res (2022) 28 (13): 2733–2737.

https://doi.org/10.1158/1078-0432.CCR-21-4462

Published: 01 July 2022

View articletitled, FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

Journal Articles

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

Clin Cancer Res (2022) 28 (11): 2221–2228.

https://doi.org/10.1158/1078-0432.CCR-21-3844

Published: 01 June 2022

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

Journal Articles

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer

Clin Cancer Res (2022) 28 (8): 1487–1492.

https://doi.org/10.1158/1078-0432.CCR-21-3247

Published: 14 April 2022

View articletitled, FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer

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

Clin Cancer Res (2022) 28 (8): 1482–1486.

https://doi.org/10.1158/1078-0432.CCR-21-3074

Published: 14 April 2022

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

Journal Articles

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

Clin Cancer Res (2022) 28 (6): 1072–1086.

https://doi.org/10.1158/1078-0432.CCR-21-2600

Published: 15 March 2022

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

Journal Articles

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

Clin Cancer Res (2022) 28 (6): 1058–1071.

https://doi.org/10.1158/1078-0432.CCR-21-2599

Published: 15 March 2022

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

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

Clin Cancer Res (2022) 28 (3): 446–451.

https://doi.org/10.1158/1078-0432.CCR-21-1466

Published: 01 February 2022

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

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

Clin Cancer Res (2022) 28 (3): 441–445.

https://doi.org/10.1158/1078-0432.CCR-21-2334

Published: 01 February 2022

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

Journal Articles

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

Clin Cancer Res (2022) 28 (2): 249–254.

https://doi.org/10.1158/1078-0432.CCR-21-1566

Published: 19 January 2022

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

Journal Articles

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

Clin Cancer Res (2021) 27 (24): 6638–6643.

https://doi.org/10.1158/1078-0432.CCR-21-1034

Published: 15 December 2021

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

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

Clin Cancer Res (2021) 27 (21): 5753–5756.

https://doi.org/10.1158/1078-0432.CCR-20-4912

Published: 01 November 2021

View articletitled, Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Journal Articles

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

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

Includes: Supplementary data

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FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

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

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

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

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

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

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

FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer

FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

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

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer

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

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

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

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

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

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

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

Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

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

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