Publications by authors named "Gideon Blumenthal"

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Optimizing public-private partnerships to support clinical cancer research.
Roy S Herbst, Gideon Blumenthal, Samir N Khleif, Scott M Lippman, Neal J Meropol

J Natl Cancer Inst· July 2025

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US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies.
Joseph M Gendy, Naomi Nomura, Jeffrey N Stuart, Gideon Blumenthal

Ther Innov Regul Sci· March 2024

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The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial Data.
Qi Liu, Raina Mathur, Yuan Xu, Aracelis Z Torres, Rebecca A Miksad, Gideon Michael Blumenthal

Clin Pharmacol Ther· May 2023

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Clinical Trial Diversity in Oncology: FDA Takes Action with Post-Marketing Requirements or Commitments.
Janice Kim, Robert Kester, Gideon Blumenthal

Oncologist· December 2022

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Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses.
Kelly J Norsworthy, Xin Gao, Chia-Wen Ko, E Dianne Pulte, Jiaxi Zhou, Gideon M Blumenthal

J Clin Oncol· March 2022

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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, Gideon M Blumenthal

Oncologist· October 2021

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Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.
Jeremy Mason, Yutao Gong, Laleh Amiri-Kordestani, Suparna Wedam, Jennifer J Gao, Gideon M Blumenthal

JCO Clin Cancer Inform· June 2021

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Second cancers in adults with acute promyelocytic leukemia treated with or without arsenic trioxide: a SEER-medicare analysis.
Kelly J Norsworthy, Armen Avagyan, Steven T Bird, Yuchen Li, Sandia Akhtar, Gideon Blumenthal

Leukemia· November 2020

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Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation.
Bindu Kanapuru, Harpreet Singh, Virginia Kwitkowski, Gideon Blumenthal, Ann T Farrell

Blood Rev· September 2020

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Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer.
Phil Bonomi, Nina Stuccio, C J Delgra, Meredith K Chuk, Alexander Spira, Gideon M Blumenthal

Ther Innov Regul Sci· September 2020

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Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives of a Multistakeholder Working Group.
Patrick M Forde, Phil Bonomi, Alice Shaw, Gideon M Blumenthal, Andrea Ferris

Clin Lung Cancer· July 2020

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FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1.
Preeti Narayan, Sakar Wahby, Jennifer J Gao, Laleh Amiri-Kordestani, Amna Ibrahim, Gideon M Blumenthal

Clin Cancer Res· May 2020

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Application of Machine Learning in Drug Development and Regulation: Current Status and Future Potential.
Qi Liu, Hao Zhu, Chao Liu, Daphney Jean, Shiew-Mei Huang, Gideon Blumenthal

Clin Pharmacol Ther· April 2020

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Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.
Phillip G Febbo, Anne-Marie Martin, Howard I Scher, J Carl Barrett, Julia A Beaver, Gideon M Blumenthal

Clin Pharmacol Ther· April 2020

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Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.
Janice Kim, Abhilasha Nair, Patricia Keegan, Julia A Beaver, Paul G Kluetz, Gideon M Blumenthal

Oncologist· April 2020

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Approvals in 2019: international review and a new agnostic molecular entity.
Harpreet Singh, Gideon Blumenthal, Richard Pazdur

Nat Rev Clin Oncol· March 2020

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Development, Validation, and Regulatory Considerations for a Liquid Biopsy Test.
Dana W Y Tsui, Gideon M Blumenthal, Reena Philip, J Carl Barrett, Clara Montagut

Clin Chem· March 2020

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An Analysis of Recent FDA Oncology Scientific Publications.
Julie A Schneider, Andrew C Miklos, James Onken, Yutao Gong, Anna Maria Calcagno, Gideon M Blumenthal

Oncologist· March 2020

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FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.
Emily Y Jen, Xin Gao, Liang Li, Luning Zhuang, Natalie E Simpson, Gideon M Blumenthal

Clin Cancer Res· February 2020

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Application of the Lung Immune Prognostic Index From Research to Clinical Practice-Reply.
Dickran Kazandjian, Yutao Gong, Gideon M Blumenthal

JAMA Oncol· February 2020

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CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.
Jennifer J Gao, Joyce Cheng, Erik Bloomquist, Jacquelyn Sanchez, Suparna B Wedam, Gideon M Blumenthal

Lancet Oncol· February 2020

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FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
Donna Przepiorka, Lola Luo, Sriram Subramaniam, Junshan Qiu, Ramadevi Gudi, Gideon M Blumenthal

Oncologist· February 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, Gideon M Blumenthal

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, Gideon M Blumenthal

JAMA Oncol· December 2019

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Global Variation in Opioid Use in Prostate Cancer Trials.
Jessica K Roydhouse, Daniel L Suzman, Laurel A Menapace, Pallavi S Mishra-Kalyani, Rajeshwari Sridhara, Gideon M Blumenthal

JAMA Oncol· November 2019

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