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Author Details

Gideon M Blumenthal
Oncology Center of Excellence
2008
108
46
PMIDPaper TitleJournal TitlePublished Year
36790088The 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.Clin Pharmacol Ther2023
34890212Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses.J Clin Oncol2022
34196068Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health.Oncologist2021
34297598Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.JCO Clin Cancer Inform2021
31444252FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.Clin Cancer Res2020
32001481FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1.Clin Cancer Res2020
31750870Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer.JAMA Oncol2020
31925955Application of Machine Learning in Drug Development and Regulation: Current Status and Future Potential.Clin Pharmacol Ther2020
32047277Approvals in 2019: international review and a new agnostic molecular entity.Nat Rev Clin Oncol2020
32017048Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.Clin Pharmacol Ther2020
31774473Application of the Lung Immune Prognostic Index From Research to Clinical Practice-Reply.JAMA Oncol2020
31859246CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.Lancet Oncol2020
32043777FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.Oncologist2020
32091082Development, Validation, and Regulatory Considerations for a Liquid Biopsy Test.Clin Chem2020
32865803Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer.Ther Innov Regul Sci2020
32241586Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation.Blood Rev2020
32518418Second cancers in adults with acute promyelocytic leukemia treated with or without arsenic trioxide: a SEER-medicare analysis.Leukemia2020
32297444Evaluation of Serious Postmarket Safety Signals Within 2â¿¿Years of FDA Approval for New Cancer Drugs.Oncologist2020
32201247Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives of a Multistakeholder Working Group.Clin Lung Cancer2020
32162806An Analysis of Recent FDA Oncology Scientific Publications.Oncologist2020
31548341FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.Clin Cancer Res2020
29529128Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.Ann Oncol2019
31670753Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer.JAMA Oncol2019
32914013Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, US Food and Drug Administration Public Workshop-Workshop Proceedings.JCO Precis Oncol2019
31470129Radiologic Considerations and Standardization of Malignant Pleural Mesothelioma Imaging Within Clinical Trials: Consensus Statement from the NCI Thoracic Malignancy Steering Committee - International Association for the Study of Lung Cancer - Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting.J Thorac Oncol2019
31350329A Pilot Study of Sirolimus in Subjects with Cowden Syndrome or Other Syndromes Characterized by Germline Mutations in <i>PTEN</i>.Oncologist2019
31343662Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer.JAMA Oncol2019
31513232Global Variation in Opioid Use in Prostate Cancer Trials.JAMA Oncol2019
31367538A phase I/II study of pemetrexed with sirolimus in advanced, previously treated non-small cell lung cancer.Transl Lung Cancer Res2019
30914464FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma.Oncologist2019
30880446Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions.Clin Trials2019
30723888Model-Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First-Line Anaplastic Lymphoma Kinase + Non-Small Cell Lung Cancer.Clin Pharmacol Ther2019
30817750Reproducibility of pharmacogenetics findings for paclitaxel in a heterogeneous population of patients with lung cancer.PLoS One2019
30498095Clinical Development of Novel Drug-Radiotherapy Combinations.Clin Cancer Res2019
30552112FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer.Clin Cancer Res2019
30541745FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.Clin Cancer Res2019
30670830Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review.Nat Rev Clin Oncol2019
30591549Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.Oncologist2019
30413526FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma.Clin Cancer Res2019
30696689Challenges with Novel Clinical Trial Designs: Master Protocols.Clin Cancer Res2019
28901535A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.Clin Pharmacol Ther2018
30268698Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer.J Thorac Oncol2018
30266660Current and Future Management of Malignant Mesothelioma: A Consensus Report from the National Cancer Institute Thoracic Malignancy Steering Committee, International Association for the Study of Lung Cancer, and Mesothelioma Applied Research Foundation.J Thorac Oncol2018
30482633Age-related differences in patient-reported outcomes in patients with advanced lung cancer receiving anti-PD-1/PD-L1 therapy.Semin Oncol2018
30391014FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies.Semin Oncol2018
29361469Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis.Lancet Oncol2018
29473145Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.Clin Pharmacol Ther2018
29523624U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.Clin Cancer Res2018
29494733A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.JAMA Oncol2018
29384145Approvals in 2017: gene therapies and site-agnostic indications.Nat Rev Clin Oncol2018
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Collaborators

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Meyer Cancer Center
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Illumina Inc.
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Duke University Medical Center
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Lineberger Comprehensive Cancer Center, University of North Carolina
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Decipher Biosciences Inc.
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