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Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials

Clinical cancer research, 2018-05, Vol.24 (10), p.2268-2275

2018

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Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

Journal of clinical oncology, 2017-11, Vol.35 (33), p.3745-3752

2017

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U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

Clinical cancer research, 2017-07, Vol.23 (14), p.3484-3488

2017

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Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody

Journal of clinical oncology, 2019-10, Vol.37 (30), p.JCO1900318-2737

2019

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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Clinical cancer research, 2016-04, Vol.22 (7), p.1553-1558

2016

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Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

Journal of clinical oncology, 2017-11, Vol.35 (33), p.3737-3744

2017

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Exploration of a Novel Intermediate Response Endpoint in Immunotherapy Clinical Studies

Clinical cancer research, 2018-05, Vol.24 (10), p.2262-2267

2018

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FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis

Clinical cancer research, 2020-10, Vol.26 (19), p.5062-5067

2020

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Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections

Clinical cancer research, 2018-04, Vol.24 (8), p.1780-1784

2018

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FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer

Clinical cancer research, 2017-12, Vol.23 (23), p.7165-7170

2017

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FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer

Clinical cancer research, 2020-08, Vol.26 (16), p.4180-4185

2020

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U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Clinical cancer research, 2018-08, Vol.24 (15), p.3486-3491

2018

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FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Clinical cancer research, 2017-10, Vol.23 (19), p.5661-5665

2017

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FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Clinical cancer research, 2018-07, Vol.24 (13), p.2999-3004

2018

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FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma

Clinical cancer research, 2017-07, Vol.23 (14), p.3479-3483

2017

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Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis

Journal for immunotherapy of cancer, 2020-02, Vol.8 (1), p.e000146

2020

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U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

Clinical cancer research, 2013-09, Vol.19 (17), p.4559-4563

2013

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United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy

Clinical cancer research, 2006-05, Vol.12 (10), p.2955-2960

2006

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Bortezomib for the Treatment of Mantle Cell Lymphoma

Clinical cancer research, 2007-09, Vol.13 (18), p.5291-5294

2007

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Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary

Clinical cancer research, 2014, Vol.20 (1), p.9-14

2014

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FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy

The oncologist (Dayton, Ohio), 2017-11, Vol.22 (11), p.1347-1353

2017

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FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma

The oncologist (Dayton, Ohio), 2010-04, Vol.15 (4), p.428-435

2010

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FDA Approval Summary: Sunitinib for the Treatment of Progressive Well‐Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

The oncologist (Dayton, Ohio), 2012-08, Vol.17 (8), p.1108-1113

2012

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Sorafenib for the Treatment of Advanced Renal Cell Carcinoma

Clinical cancer research, 2006-12, Vol.12 (24), p.7271-7278

2006

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U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma

Clinical cancer research, 2017-01, Vol.23 (2), p.330-335

2017

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Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials

Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

Exploration of a Novel Intermediate Response Endpoint in Immunotherapy Clinical Studies

FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis

Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer

FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma

Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis

U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy

Bortezomib for the Treatment of Mantle Cell Lymphoma

Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary

FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy

FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma

FDA Approval Summary: Sunitinib for the Treatment of Progressive Well‐Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

Sorafenib for the Treatment of Advanced Renal Cell Carcinoma

U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma

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