Publications by authors named "Sundeep Agrawal"

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FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.
William F Maguire, Dow-Chung Chi, Sundeep Agrawal, Hee-Koung Joeng, Sarah Kim-McOlash

Clin Cancer Res· September 2025

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FDA approvals in 2024: new options for patients across cancer types and therapeutic classes.
Sundeep Agrawal, Esther Park, Paul G Kluetz

Nat Rev Clin Oncol· July 2025

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The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials.
Elaine Chang, Haley Gittleman, Chi Song, Erik Bloomquist, Laura Fernandes, Sundeep Agrawal

JNCI Cancer Spectr· July 2025

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FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.
Sundeep Agrawal, Clara Lee, William F Pierce, Elizabeth Everhart, Adriene King-Ducre

Clin Cancer Res· December 2024

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Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies.
Jaleh Fallah, Flora Mulkey, Mallorie H Fiero, Haley Gittleman, Chi Song, Sundeep Agrawal

J Clin Oncol· November 2024

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RE: Is it time to reconsider the role of upfront cytoreductive nephrectomy in metastatic renal cell carcinoma?
Jaleh Fallah, Haley Gittleman, Chana Weinstock, Elaine Chang, Sundeep Agrawal

J Natl Cancer Inst· September 2024

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A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma.
Elaine Chang, Jiaxi Zhou, Chi Song, Haley Gittleman, Laura Fernandes, Sundeep Agrawal

Clin Cancer Res· August 2024

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False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring and Mutations.
Jaleh Fallah, Jianjin Xu, Hee-Koung Joeng, Chana Weinstock, Brian L Heiss, Sundeep Agrawal

JCO Precis Oncol· August 2024

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Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis.
Jaleh Fallah, Haley Gittleman, Chana Weinstock, Elaine Chang, Sundeep Agrawal

J Natl Cancer Inst· July 2024

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FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma.
William F Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C Bulik, Sundeep Agrawal

Clin Cancer Res· May 2024

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Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis.
Jaleh Fallah, Jianjin Xu, Chana Weinstock, Xin Gao, Brian L Heiss, Sundeep Agrawal

J Clin Oncol· May 2024

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A U.S. Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma.
Daniel Lee, Haley Gittleman, Chana Weinstock, Daniel Suzman, Erik Bloomquist, Sundeep Agrawal

Eur Urol· October 2023

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Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.
Elaine Chang, Noah M Hahn, Seth P Lerner, Jaleh Fallah, Sundeep Agrawal

Bladder Cancer· September 2023

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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

Clin Cancer Res· May 2023

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Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
Sundeep Agrawal, Shaily Arora, Laleh Amiri-Kordestani, R Angelo de Claro, Lola Fashoyin-Aje

JAMA Oncol· February 2023

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Prostate Cancer Theranostics: Concurrent Approvals by the Food and Drug Administration of the First Diagnostic Imaging Drug Indicated to Select Patients for a Paired Radioligand Therapeutic Drug.
A Alex Hofling, Anthony F Fotenos, Gang Niu, Jaleh Fallah, Sundeep Agrawal

J Nucl Med· November 2022

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Optimizing Clinical Trial Design for Patients with Non-muscle-invasive Bladder Cancer.
Chana Weinstock, Sundeep Agrawal, Elaine Chang

Eur Urol· July 2022

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Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress.
Donna R Rivera, Paul G Kluetz, Kald Abdallah, Sundeep Agrawal, Derek C Angus

Cancer J· March 2022

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Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature.
Connie Cheng, Michelle Nadeau Nguyen, Afrouz Nayernama, S Christopher Jones, Michael Brave, Sundeep Agrawal

Vasc Med· October 2021

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Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials.
Jaleh Fallah, Lijun Zhang, Anup Amatya, Yutao Gong, Bellinda King-Kallimanis, Sundeep Agrawal

Lancet Oncol· September 2021

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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, Sundeep Agrawal

Clin Cancer Res· February 2021

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Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies.
Jamie R Brewer, Elaine Chang, Sundeep Agrawal, Harpreet Singh, Daniel L Suzman

Clin Cancer Res· December 2020

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Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer.
Sundeep Agrawal, Naomi B Haas, Mohammadhadi Bagheri, Brian R Lane, Jonathan Coleman

JAMA Oncol· January 2020

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Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer.
Andrea B Apolo, Matthew I Milowsky, Lauren Kim, Brant A Inman, Ashish M Kamat, Sundeep Agrawal

JAMA Oncol· December 2019

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FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Daniel L Suzman, Sundeep Agrawal, Yang-Min Ning, V Ellen Maher, Laura L Fernandes

Oncologist· April 2019

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