1-20 of 37
Paul G. Kluetz
Close
Save search
Follow your search
Access your saved searches in your account
Would you like to receive an alert when new items match your search?
Close Modal
Sort by
Journal Articles

FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma

Timil H. Patel, Jamie R. Brewer, Jiaxin Fan, Joyce Cheng, Yuan-Li Shen, Yue Xiang, Hong Zhao, Steven J. Lemery, Richard Pazdur, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF5.
https://doi.org/10.1158/1078-0432.CCR-23-2124
Published: 21 September 2023
View article titled, FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma
Open the PDF for FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma in another window
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 OF1–OF6.
https://doi.org/10.1158/1078-0432.CCR-23-1270
Published: 12 September 2023
View article titled, FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
Open the PDF for FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Jennifer J. Gao, Christy L. Osgood, Zhou Feng, Erik W. Bloomquist, Shenghui Tang, C.J. George Chang, Tiffany K. Ricks, Sherry C. Hou, William F. Pierce, Donna R. Rivera, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF4.
https://doi.org/10.1158/1078-0432.CCR-23-1133
Published: 07 September 2023
View article titled, FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Open the PDF for FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer in another window
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 OF1–OF6.
https://doi.org/10.1158/1078-0432.CCR-23-1503
Published: 07 September 2023
View article titled, FDA Approval Summary: Dabrafenib in Combination with Trametinib for <em>BRAF</em><sup>V600E</sup> Mutation–Positive Low-Grade Glioma
Open the PDF for FDA Approval Summary: Dabrafenib in Combination with Trametinib for <em>BRAF</em><sup>V600E</sup> Mutation–Positive Low-Grade Glioma in another window
Journal Articles

FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer

Sandra J. Casak, M. Naomi Horiba, Mengdie Yuan, Joyce Cheng, Steven J. Lemery, Yuan Li Shen, Wentao Fu, Jason N. Moore, Yangbing Li, Youwei Bi, Doris Auth, Nataliya Fesenko, Paul G. Kluetz, Richard Pazdur, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF5.
https://doi.org/10.1158/1078-0432.CCR-23-1041
Published: 29 June 2023
View article titled, FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, <em>HER2</em>-Positive <em>RAS</em> Wild-Type Colorectal Cancer
Open the PDF for FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, <em>HER2</em>-Positive <em>RAS</em> Wild-Type Colorectal Cancer in another window
Journal Articles

FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements

Shruti U. Gandhy, Sandra J. Casak, Sirisha L. Mushti, Joyce Cheng, Sriram Subramaniam, Hong Zhao, Miao Zhao, Youwei Bi, Guansheng Liu, Jianghong Fan, Oluseyi Adeniyi, Rosane Charlab, Dubravka Kufrin, Matthew D. Thompson, Kristin Jarrell, Doris Auth, Steven J. Lemery, Richard Pazdur, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF5.
https://doi.org/10.1158/1078-0432.CCR-23-1042
Published: 27 June 2023
View article titled, FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
Open the PDF for FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements in another window
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 OF1–OF6.
https://doi.org/10.1158/1078-0432.CCR-23-0991
Published: 07 June 2023
View article titled, FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer
Open the PDF for FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer in another window
Journal Articles

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer

Jaleh Fallah, Sundeep Agrawal, Haley Gittleman, Mallorie H. Fiero, Sriram Subramaniam, Christy John, Wei Chen, Tiffany K. Ricks, Gang Niu, Anthony Fotenos, Min Wang, Kelly Chiang, William F. Pierce, Daniel L. Suzman, Shenghui Tang, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Paul G. Kluetz
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (9): 1651–1657.
https://doi.org/10.1158/1078-0432.CCR-22-2875
Published: 01 May 2023
View article titled, FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer
Open the PDF for FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer in another window
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
Open the PDF for FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease in another window
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
Open the PDF for FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation in another window
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
Open the PDF for FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma in another window
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
Open the PDF for Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples in another window
Journal Articles

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Julie A. Schneider, Yutao Gong, Kirsten B. Goldberg, Paul G. Kluetz, Marc R. Theoret, Laleh Amiri-Kordestani, Julia A. Beaver, Lola Fashoyin-Aje, Nicole J. Gormley, Adnan A. Jaigirdar, Steven J. Lemery, Pallavi S. Mishra-Kalyani, Gregory H. Reaman, Donna R. Rivera, Wendy S. Rubinstein, Harpreet Singh, Rajeshwari Sridhara, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (19): 5161–5167.
https://doi.org/10.1158/1078-0432.CCR-20-4429
Published: 01 October 2021
View article titled, The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
Open the PDF for The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

Sandra J. Casak, Leigh Marcus, Lola Fashoyin-Aje, Sirisha L. Mushti, Joyce Cheng, Yuan-Li Shen, William F. Pierce, Leah Her, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (17): 4680–4684.
https://doi.org/10.1158/1078-0432.CCR-21-0557
Published: 01 September 2021
View article titled, FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma
Open the PDF for FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma in another window
Journal Articles

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group

Allison Magnuson, Suanna S. Bruinooge, Harpreet Singh, Keith D. Wilner, Shadia Jalal, Stuart M. Lichtman, Paul G. Kluetz, Gary H. Lyman, Heidi D. Klepin, Mark E. Fleury, Brad Hirsch, Allen Melemed, Fernanda I. Arnaldez, Upal Basu Roy, Caroline Schenkel, Shimere Sherwood, Elizabeth Garrett-Mayer
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2424–2429.
https://doi.org/10.1158/1078-0432.CCR-20-3868
Published: 01 May 2021
View article titled, Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group
Open the PDF for Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group in another window
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
Open the PDF for FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer in another window
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 article titled, FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with <em>RET</em> Gene Mutations or Fusions
Open the PDF for FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with <em>RET</em> Gene Mutations or Fusions in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Sandra J. Casak, Martha Donoghue, Lola Fashoyin-Aje, Xiaoping Jiang, Lisa Rodriguez, Yuan-Li Shen, Yuan Xu, Xiling Jiang, Jiang Liu, Hong Zhao, William F. Pierce, Shubhangi Mehta, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1836–1841.
https://doi.org/10.1158/1078-0432.CCR-20-3407
Published: 01 April 2021
View article titled, FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
Open the PDF for FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma in another window
Journal Articles

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1842–1849.
https://doi.org/10.1158/1078-0432.CCR-20-3652
Published: 01 April 2021
View article titled, FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
Open the PDF for FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer in another window
Journal Articles

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue, William F. Pierce, Stacy S. Shord, Jennifer J. Gao, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (4): 916–921.
https://doi.org/10.1158/1078-0432.CCR-20-3213
Published: 15 February 2021
View article titled, FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
Open the PDF for FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs in another window