Paul G Kluetz (Paul Kluetz)

Publication Activity (10 Years)

Years Active: 2022-2024
Publications (10 Years): 47

Top Topics

Renal Cell Carcinoma

Small Cell Lung Cancer

Top Venues

Clinical cancer research : an official journal of the American Association for Cancer Research

Cancer discovery

Journal of the National Cancer Institute

Cancer research communications

This page only lists publications with an associated author ORCID identifier.

Publications

William F Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C Bulik, Sundeep Agrawal, Elaine Chang, Salaheldin S Hamed, Erik W Bloomquist, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Laleh Amiri-Kordestani, Daniel L Suzman
FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (10) (2024)
William F Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C Bulik, Sundeep Agrawal, Elaine Chang, Salaheldin S Hamed, Erik W Bloomquist, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Laleh Amiri-Kordestani, Daniel L Suzman
FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (10) (2024)
Jaleh Fallah, Brian L Heiss, Hee-Koung Joeng, Chana Weinstock, Xin Gao, William F Pierce, Benjamin Chukwurah, Vishal Bhatnagar, Mallorie H Fiero, Laleh Amiri-Kordestani, Richard Pazdur, Paul G Kluetz, Daniel L Suzman
FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
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 Atiqur Rahman, Richard Pazdur, Harpreet Singh, Paul G Kluetz, Nicole Drezner
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (16) (2024)
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 Atiqur Rahman, Richard Pazdur, Harpreet Singh, Paul G Kluetz, Nicole Drezner
FDA Approval Summary: Repotrectinib for locally advanced or metastatic ROS1-positive non-small cell lung cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Jason R Fangusaro, Robert A Avery, Michael J Fisher, Roger J Packer, Karin S Walsh, Antoinette Y N Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G Kluetz, Martha Donoghue, Elizabeth S Duke
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (11) (2024)
Sandra J Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan, Anup K Amatya, Joyce Cheng, Pallavi S Mishra-Kalyani, Shenghui Tang, Steven J Lemery, Doris Auth, Gina Davis, Paul G Kluetz, Richard Pazdur, Lola A Fashoyin-Aje
FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint inhibitors for the Treatment of Biliary Tract Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Sandra J Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan, Anup K Amatya, Joyce Cheng, Pallavi S Mishra-Kalyani, Shenghui Tang, Steven J Lemery, Doris Auth, Gina Davis, Paul G Kluetz, Richard Pazdur, Lola A Fashoyin-Aje
FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (16) (2024)
Sandra J Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan, Anup K Amatya, Joyce Cheng, Pallavi S Mishra-Kalyani, Shenghui Tang, Steven J Lemery, Doris Auth, Gina Davis, Paul G Kluetz, Richard Pazdur, Lola A Fashoyin-Aje
FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (16) (2024)
Jason R Fangusaro, Robert A Avery, Michael J Fisher, Roger J Packer, Karin S Walsh, Antoinette Y N Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G Kluetz, Martha Donoghue, Elizabeth S Duke
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Timil H Patel, Christopher T Chen, Samer Al Hadidi, Yasmin A Kadry, Rajeshwari Sridhara, Erin Purcell, Laura Wisch, Jon Retzlaff, Margaret Foti, Richard Pazdur, Paul G Kluetz, Jennifer J Gao
Reflections and Roadmaps: Career Development beyond the FDA-AACR Oncology Educational Fellowship. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (15) (2024)
Jason R Fangusaro, Robert A Avery, Michael J Fisher, Roger J Packer, Karin S Walsh, Antoinette Y N Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G Kluetz, Martha Donoghue, Elizabeth S Duke
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (11) (2024)
Michael J Fusco, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Brian J Christmas, Matthew D Thompson, Wentao Fu, Hezhen Wang, Miyoung Yoon, Yuching Yang, Jason N Moore, Youwei Bi, Yang Nan, Craig E Long, Doris Auth, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Lola A Fashoyin-Aje, Paul G Kluetz, Steven J Lemery
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Michael J Fusco, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Brian J Christmas, Matthew D Thompson, Wentao Fu, Hezhen Wang, Miyoung Yoon, Yuching Yang, Jason N Moore, Youwei Bi, Yang Nan, Craig E Long, Doris Auth, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Lola A Fashoyin-Aje, Paul G Kluetz, Steven J Lemery
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (15) (2024)
Elaine Chang, Jiaxi Zhou, Chi Song, Haley Gittleman, Laura L Fernandes, Chana Weinstock, Michael B Atkins, Sundeep Agrawal, Rajeshwari Sridhara, Nicole J Gormley, Shenghui Tang, Daniel L Suzman, Laleh Amiri-Kordestani, Paul G Kluetz, Richard Pazdur, Brian I Rini, David F McDermott, Meredith M Regan
A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Sandra J Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan, Anup K Amatya, Joyce Cheng, Pallavi S Mishra-Kalyani, Shenghui Tang, Steven J Lemery, Doris Auth, Gina Davis, Paul G Kluetz, Richard Pazdur, Lola A Fashoyin-Aje
FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (16) (2024)
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
FDA Approval Summary: Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Elaine Chang, Jiaxi Zhou, Chi Song, Haley Gittleman, Laura L Fernandes, Chana Weinstock, Michael B Atkins, Sundeep Agrawal, Rajeshwari Sridhara, Nicole J Gormley, Shenghui Tang, Daniel L Suzman, Laleh Amiri-Kordestani, Paul G Kluetz, Richard Pazdur, Brian I Rini, David F McDermott, Meredith M Regan
A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (15) (2024)
Michael J Fusco, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Brian J Christmas, Matthew D Thompson, Wentao Fu, Hezhen Wang, Miyoung Yoon, Yuching Yang, Jason N Moore, Youwei Bi, Yang Nan, Craig E Long, Doris Auth, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Lola A Fashoyin-Aje, Paul G Kluetz, Steven J Lemery
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (15) (2024)
William F Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C Bulik, Sundeep Agrawal, Elaine Chang, Salaheldin S Hamed, Erik W Bloomquist, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Laleh Amiri-Kordestani, Daniel L Suzman
FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (10) (2024)
Jaleh Fallah, Haley Gittleman, Chana Weinstock, Elaine Chang, Sundeep Agrawal, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Daniel L Suzman, Laleh Amiri-Kordestani
Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis. Journal of the National Cancer Institute 116 (7) (2024)
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 Atiqur Rahman, Richard Pazdur, Harpreet Singh, Paul G Kluetz, Nicole Drezner
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (16) (2024)
Michael J Fusco, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Brian J Christmas, Matthew D Thompson, Wentao Fu, Hezhen Wang, Miyoung Yoon, Yuching Yang, Jason N Moore, Youwei Bi, Yang Nan, Craig E Long, Doris Auth, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Lola A Fashoyin-Aje, Paul G Kluetz, Steven J Lemery
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (15) (2024)
Jason R Fangusaro, Robert A Avery, Michael J Fisher, Roger J Packer, Karin S Walsh, Antoinette Y N Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G Kluetz, Martha Donoghue, Elizabeth S Duke
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
William F Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C Bulik, Sundeep Agrawal, Elaine Chang, Salaheldin S Hamed, Erik W Bloomquist, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Laleh Amiri-Kordestani, Daniel L Suzman
FDA Approval Summary: Enfortumab Vedotin Plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Jason R Fangusaro, Robert A Avery, Michael J Fisher, Roger J Packer, Karin S Walsh, Antoinette Y N Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G Kluetz, Martha Donoghue, Elizabeth S Duke
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (11) (2024)
Jason R Fangusaro, Robert A Avery, Michael J Fisher, Roger J Packer, Karin S Walsh, Antoinette Y N Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G Kluetz, Martha Donoghue, Elizabeth S Duke
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (11) (2024)
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 Atiqur Rahman, Richard Pazdur, Harpreet Singh, Paul G Kluetz, Nicole Drezner
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 30 (16) (2024)
Timil H Patel, Christopher T Chen, Samer Al Hadidi, Yasmin A Kadry, Rajeshwari Sridhara, Erin Purcell, Laura Wisch, Jon Retzlaff, Margaret Foti, Richard Pazdur, Paul G Kluetz, Jennifer J Gao
Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship. Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Joshua M Donaldson, Marjilla Seddiq, Michael J Fusco, Shyamli Singla, Gulsum E Pamuk, Rosa J Lee-Alonso, Bronwyn D Mixter, Kirsten B Goldberg, Laleh Amiri-Kordestani, R Angelo de Claro, Nicole Drezner, Nicole J Gormley, Bindu Kanapuru, Steven J Lemery, Lola A Fashoyin-Aje, Nicholas C Richardson, Harpreet Singh, Daniel L Suzman, Marc R Theoret, Paul G Kluetz, Richard Pazdur
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development. Cancer discovery 13 (12) (2023)
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
FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
Joshua M Donaldson, Marjilla Seddiq, Michael J Fusco, Shyamli Singla, Gulsum E Pamuk, Rosa J Lee-Alonso, Bronwyn D Mixter, Kirsten B Goldberg, Laleh Amiri-Kordestani, R Angelo de Claro, Nicole Drezner, Nicole J Gormley, Bindu Kanapuru, Steven J Lemery, Lola A Fashoyin-Aje, Nicholas C Richardson, Harpreet Singh, Daniel L Suzman, Marc R Theoret, Paul G Kluetz, Richard Pazdur
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development. Cancer discovery 13 (12) (2023)
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
FDA Approval Summary: Alpelisib for PIK3CA-related Overgrowth Spectrum (PROS). Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
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
FDA Approval Summary: Dabrafenib in combination with trametinib for BRAF V600E mutation-positive low-grade glioma. Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
Qi Liu, Chenan Zhang, Yue Huang, Ruihao Huang, Shiew Mei Huang, Erin Larkins, Liza Stapleford, Donna R Rivera, Paul G Kluetz, Shenggang Wang, Hao Zhu, James L Weese, Elizabeth Cromartie, Mahder Teka, Sheetal Walters, Frank M Wolf, Thomas D Brown
Evaluating Pneumonitis Incidence in Patients with Non-small Cell Lung Cancer Treated with Immunotherapy and/or Chemotherapy Using Real-world and Clinical Trial Data. Cancer research communications 3 (2) (2023)
Joshua M Donaldson, Marjilla Seddiq, Michael J Fusco, Shyamli Singla, Gulsum E Pamuk, Rosa J Lee-Alonso, Bronwyn D Mixter, Kirsten B Goldberg, Laleh Amiri-Kordestani, R Angelo de Claro, Nicole Drezner, Nicole J Gormley, Bindu Kanapuru, Steven J Lemery, Lola A Fashoyin-Aje, Nicholas C Richardson, Harpreet Singh, Daniel L Suzman, Marc R Theoret, Paul G Kluetz, Richard Pazdur
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development. Cancer discovery 13 (12) (2023)
Qi Liu, Chenan Zhang, Yue Huang, Ruihao Huang, Shiew Mei Huang, Erin Larkins, Liza Stapleford, Donna R Rivera, Paul G Kluetz, Shenggang Wang, Hao Zhu, James L Weese, Elizabeth Cromartie, Mahder Teka, Sheetal Walters, Frank M Wolf, Thomas D Brown
Evaluating Pneumonitis Incidence in Patients with Non-small Cell Lung Cancer Treated with Immunotherapy and/or Chemotherapy Using Real-world and Clinical Trial Data. Cancer research communications 3 (2) (2023)
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
FDA Approval Summary: Mirvetuximab soravtansine-gynx for FRα-positive, Platinum-Resistant Ovarian Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
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
FDA Approval Summary: Tremelimumab in combination with durvalumab for the treatment of patients with unresectable hepatocellular carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
Joshua M Donaldson, Marjilla Seddiq, Michael J Fusco, Shyamli Singla, Gulsum E Pamuk, Rosa J Lee-Alonso, Bronwyn D Mixter, Kirsten B Goldberg, Laleh Amiri-Kordestani, R Angelo de Claro, Nicole Drezner, Nicole J Gormley, Bindu Kanapuru, Steven J Lemery, Lola A Fashoyin-Aje, Nicholas C Richardson, Harpreet Singh, Daniel L Suzman, Marc R Theoret, Paul G Kluetz, Richard Pazdur
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development. Cancer discovery 13 (12) (2023)
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
FDA Approval Summary: Tucatinib with trastuzumab for advanced unresectable or metastatic, chemotherapy refractory, HER2 positive RAS wild type colorectal cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
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
FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements. Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
Donna R Rivera, Erin Larkins, Paul G Kluetz
Blurring the Lines of Design: Prospective Observational Cohorts and Pragmatic Clinical Trials Characterizing Treatment Effects in Routine Cancer Care. The oncologist 27 (2) (2022)
Elizabeth S Duke, Michael J Fusco, Patrick DeMoss, Asma Dilawari, Gulsum E Pamuk, Jessica Boehmer, Bronwyn D Mixter, Kirsten B Goldberg, Paul G Kluetz, Richard Pazdur
Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development. Cancer discovery 12 (12) (2022)
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
FDA Approval Summary: Nivolumab for adjuvant treatment of adults with completely resected esophageal/gastroesophageal junction cancer and residual pathologic disease. Clinical cancer research : an official journal of the American Association for Cancer Research (2022)
Vishal Bhatnagar, Paul G Kluetz
Encouraging Rigorous Patient-Generated Data All Along the Drug Development Continuum. Journal of the National Cancer Institute 114 (10) (2022)
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
FDA Approval Summary: lutetium Lu 177 vipivotide tetraxetan for patients with metastatic castration-resistant prostate cancer. Clinical cancer research : an official journal of the American Association for Cancer Research (2022)