Publications by authors named "Steven Lemery"

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FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer.
Michael J Fusco, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Brian J Christmas, Steven J Lemery

Clin Cancer Res· August 2024

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FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer.
Sandra J Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan, Anup K Amatya, Steven J Lemery

Clin Cancer Res· August 2024

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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, Steven J Lemery

Clin Cancer Res· January 2024

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Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.
Joshua M Donaldson, Marjilla Seddiq, Michael J Fusco, Shyamli Singla, Gulsum E Pamuk, Steven J Lemery

Cancer Discov· December 2023

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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

Clin Cancer Res· November 2023

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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, Steven J Lemery

Clin Cancer Res· October 2023

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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Elizabeth S Duke, Diana Bradford, Michelle Marcovitz, Anup K Amatya, Pallavi S Mishra-Kalyani, Steven J Lemery

Clin Cancer Res· September 2023

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FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor.
Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L Mushti, Rosane Charlab, Steven J Lemery

Clin Cancer Res· June 2023

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Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma.
David J Pinato, Xiaoxue Li, Pallavi Mishra-Kalyani, Antonio D'Alessio, Claudia A M Fulgenzi, Steven Lemery

JHEP Rep· June 2023

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FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement.
Timil H Patel, Leigh Marcus, M Naomi Horiba, Martha Donoghue, Somak Chatterjee, Steven J Lemery

Clin Cancer Res· March 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, Steven Lemery

JAMA Oncol· February 2023

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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, Steven J Lemery

Clin Cancer Res· December 2022

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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, Steven J Lemery

Clin Cancer Res· July 2022

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Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond.
Steven Lemery, Richard Pazdur

Nat Rev Clin Oncol· April 2022

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Impact of an evolving regulatory landscape on skin cancer drug development in the U.S.
David M Miller, Sophia Z Shalhout, Denise Casey, Lola Fashoyin-Aje, Steven Lemery

Dermatol Online J· March 2022

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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

Clin Cancer Res· November 2021

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Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice.
David J Pinato, Thomas U Marron, Pallavi Shruti Mishra-Kalyani, Yutao Gong, Guo Wei, Steven Lemery

Eur J Cancer· November 2021

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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, Steven J Lemery

Clin Cancer Res· October 2021

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Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health.
Elaine Chang, Lorraine Pelosof, Steven Lemery, Yutao Gong, Kirsten B Goldberg

Oncologist· October 2021

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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, Steven J Lemery

Clin Cancer Res· September 2021

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FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib.
May Tun Saung, Lorraine Pelosof, Sandra Casak, Martha Donoghue, Steven Lemery

Oncologist· September 2021

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FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors.
Leigh Marcus, Lola A Fashoyin-Aje, Martha Donoghue, Mengdie Yuan, Lisa Rodriguez, Steven J Lemery

Clin Cancer Res· September 2021

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Tissue-Agnostic Drug Development: A New Path to Drug Approval.
Kyaw Z Thein, Steven J Lemery, Shivaani Kummar

Cancer Discov· September 2021

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Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy.
Lorraine Pelosof, May Tun Saung, Martha Donoghue, Sandra Casak, Sirisha Mushti, Steven Lemery

Oncologist· April 2021

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Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration-Melanoma Research Alliance Public Workshop.
Kristen L Mueller, Marc R Theoret, Steven J Lemery, Laleh Amiri-Kordestani, Charlotte E Ariyan

Clin Cancer Res· January 2021

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