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Real-world Data for Clinical Evidence Generation in Oncology

JNCI : Journal of the National Cancer Institute, 2017-11, Vol.109 (11)

2017

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Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non–Small Cell Lung Cancer

JAMA oncology, 2019-10, Vol.5 (10), p.1481

2019

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PTEN loss in the continuum of common cancers, rare syndromes and mouse models

Nature reviews. Cancer, 2011-04, Vol.11 (4), p.289-301

2011

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FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma

Clinical cancer research, 2019-03, Vol.25 (6), p.1702-1708

2019

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FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond

The oncologist (Dayton, Ohio), 2017-11, Vol.22 (11), p.1392-1399

2017

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FDA Approval Summary: Ruxolitinib for Treatment of Steroid‐Refractory Acute Graft‐Versus‐Host Disease

The oncologist (Dayton, Ohio), 2020-02, Vol.25 (2), p.e328-e334

2020

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Targeting the PI3K/Akt/mTOR pathway: Effective combinations and clinical considerations

Drug resistance updates, 2008-02, Vol.11 (1), p.32-50

2008

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Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health

The oncologist (Dayton, Ohio), 2021-10, Vol.26 (10), p.e1786-e1799

2021

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FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Clinical cancer research, 2020-02, Vol.26 (3), p.532-536

2020

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FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer

Clinical cancer research, 2015-06, Vol.21 (11), p.2436-2439

2015

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Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400

Clinical cancer research, 2015-04, Vol.21 (7), p.1514-1524

2015

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Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

Clinical cancer research, 2017-05, Vol.23 (9), p.2131-2135

2017

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Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

The oncologist (Dayton, Ohio), 2017-07, Vol.22 (7), p.762-767

2017

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Approvals in 2016: the march of the checkpoint inhibitors

Nature reviews. Clinical oncology, 2017-03, Vol.14 (3), p.131-132

2017

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FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults

Clinical cancer research, 2020-01, Vol.26 (2), p.328-331

2020

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The FDA Oncology Center of Excellence and precision medicine

Experimental biology and medicine (Maywood, N.J.), 2018-02, Vol.243 (3), p.308-312

2018

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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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FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non‐Small Cell Lung Cancer Whose Tumors Express Programmed Death‐Ligand 1

The oncologist (Dayton, Ohio), 2016-05, Vol.21 (5), p.643-650

2016

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An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Clinical cancer research, 2017-03, Vol.23 (6), p.1368-1372

2017

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FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer

Clinical cancer research, 2016-03, Vol.22 (6), p.1307-1312

2016

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Reproducibility of pharmacogenetics findings for paclitaxel in a heterogeneous population of patients with lung cancer

PloS one, 2019-02, Vol.14 (2), p.e0212097-e0212097

2019

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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

The lancet oncology, 2020-02, Vol.21 (2), p.250-260

2020

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Overestimation of the Effect Size in Group Sequential Trials

Clinical cancer research, 2012-09, Vol.18 (18), p.4872-4876

2012

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Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses

Journal of clinical oncology, 2015-03, Vol.33 (9), p.1008-1014

2015

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FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements

The oncologist (Dayton, Ohio), 2014-10, Vol.19 (10), p.e5-e11

2014

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Real-world Data for Clinical Evidence Generation in Oncology

Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non–Small Cell Lung Cancer

PTEN loss in the continuum of common cancers, rare syndromes and mouse models

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond

FDA Approval Summary: Ruxolitinib for Treatment of Steroid‐Refractory Acute Graft‐Versus‐Host Disease

Targeting the PI3K/Akt/mTOR pathway: Effective combinations and clinical considerations

Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health

FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer

Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

Approvals in 2016: the march of the checkpoint inhibitors

FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults

The FDA Oncology Center of Excellence and precision medicine

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

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non‐Small Cell Lung Cancer Whose Tumors Express Programmed Death‐Ligand 1

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer

Reproducibility of pharmacogenetics findings for paclitaxel in a heterogeneous population of patients with lung cancer

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

Overestimation of the Effect Size in Group Sequential Trials

Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses

FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements

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