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Author Details

Julia A Beaver
Center for Drug Evaluation and Research
2007
142
42
PMIDPaper TitleJournal TitlePublished Year
37624421FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum.Clin Cancer Res2024
36112541FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.Clin Cancer Res2023
37022784FDA Approval Summary: Amivantamab for the Treatment of Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.Clin Cancer Res2023
36951523FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC.Clin Cancer Res2023
37290026Continuation of Third-Generation Tyrosine Kinase Inhibitors in Second-Line Trials for <i>EGFR</i>-Mutated Non-Small-Cell Lung Cancer: Regulatory Considerations.J Clin Oncol2023
37344568Trends in the approval of cancer therapies by the FDA in the twenty-first century.Nat Rev Drug Discov2023
37141544US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer.J Clin Oncol2023
37271635A U.S. Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma.Eur Urol2023
36882084The Development of the Oncology Center of Excellence Patient-Friendly Language Glossary of Oncology Clinical Trial Terms.Oncologist2023
36780610US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer.J Clin Oncol2023
36580315Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.JAMA Oncol2023
36796877Regulatory implications of ctDNA in immuno-oncology for solid tumors.J Immunother Cancer2023
36757899Differential Protein Citrullination in Human ER- and ER+ Tumor and Adjacent Healthy Breast Tissue.Biochemistry2023
36302204Addressing Barriers to Clinical Trial Participation for Transgender People With Cancer to Improve Access and Generate Data.J Clin Oncol2023
34344795FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.Clin Cancer Res2022
35511133Analysis of Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy Using Pooled Trial Data Matched by Propensity Score-Reply.JAMA Oncol2022
35679021FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer.Clin Cancer Res2022
35727604FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.Clin Cancer Res2022
35365300US Food and Drug Administration Analysis of Patient-Reported Diarrhea and Its Impact on Function and Quality of Life in Patients Receiving Treatment for Breast Cancer.Value Health2022
35389509Reply to "Another look at floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning subscale and possible solutions".Cancer2022
36129992The On- and Off-Ramps of Oncology Accelerated Approval.N Engl J Med2022
35960160FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease.Clin Cancer Res2022
35925043FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer.Clin Cancer Res2022
35952319Changes in Circulating Tumor DNA Reflect Clinical Benefit Across Multiple Studies of Patients With Non-Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors.JCO Precis Oncol2022
36192554Accelerated approvals hit the target in precision oncology.Nat Med2022
35101885FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC.Clin Cancer Res2022
35012799Corrigendum to "Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria": [Annals of Oncology 32 (2021) 950-953].Ann Oncol2022
34916216FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.Clin Cancer Res2022
34910860The Wild West of Checkpoint Inhibitor Development.N Engl J Med2022
35175315Reexamination of Patient Autonomy and Prior Therapies in Oncology Clinical Trial Eligibility Criteria.JAMA Oncol2022
35084948FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer.J Clin Oncol2022
34903582FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.Clin Cancer Res2022
34990474In search of autophagy biomarkers in breast cancer: Receptor status and drug agnostic transcriptional changes during autophagy flux in cell lines.PLoS One2022
34989781Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy: A Pooled Analysis of Trials in the US Food and Drug Administration Database.JAMA Oncol2022
35259259FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation.Clin Cancer Res2022
34709353Immunotherapy for Patients With Small-Cell Lung Cancer-2 Gains, 2 Losses.JAMA Oncol2022
34462287FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma.Clin Cancer Res2022
34634139Floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer.Cancer2022
34508246Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop.Nat Rev Urol2022
34417198FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma.Clin Cancer Res2022
34711632U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.Clin Cancer Res2022
34711631U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.Clin Cancer Res2022
32816899U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program.Clin Cancer Res2021
33910935The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.Clin Cancer Res2021
33882220"Dangling" Accelerated Approvals in Oncology.N Engl J Med2021
33563632Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of Cancer Research Joint Research Statement.Clin Cancer Res2021
33753456FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer.Clin Cancer Res2021
33632925FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review.Clin Cancer Res2021
33856413Evaluating Cancer Drugs in Patients With Central Nervous System Metastases.JAMA Oncol2021
33687763FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.Oncologist2021
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Collaborators

Reena Philip
Center for Devices and Radiological Health
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Gideon M Blumenthal
Oncology Center of Excellence
Co-authored papers 19
Ben Ho Park
Vanderbilt University Medical Center
Co-authored papers 18
Justin Cidado
Oncology R&D
Co-authored papers 10
Pedram Argani
The Johns Hopkins Hospital
Co-authored papers 6
Antonio C Wolff
Co-authored papers 3
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Co-authored papers 3
Vered Stearns
Co-authored papers 3
Peter Kuhn
University of Tubingen
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Donna Roscoe
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Meredith M Regan
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CancerLinQ LLC, American Society of Clinical Oncology
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Jake Vinson
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Johns Hopkins University School of Medicine
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Knight Cancer Institute, Oregon Health and Sciences University
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Sara M Tolaney
Dana-Farber Cancer Institute
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Nancy U Lin
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Andrew Schade
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Robert L Grossman
University of Chicago
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Lindsey M Philpot
Mayo Clinic
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Matthew Ryder
Co-authored papers 1
Pradeep Bandaru
Howard Hughes Medical Institute, University of California berkeley
Co-authored papers 1
Carolyn Compton
College of American Pathologists
Co-authored papers 1
Daniel L Edelstein
Sysmex Inostics Inc.
Co-authored papers 1
AmirAli Talasaz
University of California San Diego Moores Cancer Center
Co-authored papers 1
Donna R Rivera
Oncology Center of Excellence
Co-authored papers 1
Austin K Mattox
Howard Hughes Medical Institute
Co-authored papers 1
James Hicks
Michelson Center for Convergent Bioscience, University of Southern California
Co-authored papers 1
Release 1.2