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First FDA Approval Agnostic of Cancer Site — When a Biomarker Defines the Indication

The New England journal of medicine, 2017-10, Vol.377 (15), p.1409-1412

2017

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FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

Clinical cancer research, 2019-07, Vol.25 (13), p.3753-3758

2019

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FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1

The oncologist (Dayton, Ohio), 2019-01, Vol.24 (1), p.103-109

2019

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FDA Drug Approval Summary: Bevacizumab (Avastin®) as Treatment of Recurrent Glioblastoma Multiforme

The oncologist (Dayton, Ohio), 2009-11, Vol.14 (11), p.1131-1138

2009

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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

Cancer cell, 2022-03, Vol.40 (3), p.277-288.e3

2022

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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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FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors

Clinical cancer research, 2021-02, Vol.27 (4), p.928-932

2021

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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: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations

The oncologist (Dayton, Ohio), 2018-06, Vol.23 (6), p.740-745

2018

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FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

Clinical cancer research, 2017-05, Vol.23 (10), p.2377-2381

2017

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FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma

The oncologist (Dayton, Ohio), 2021-03, Vol.26 (3), p.e484-e491

2021

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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 Drug Approval Summary: Bevacizumab (Avastin®) Plus Carboplatin and Paclitaxel as First‐Line Treatment of Advanced/Metastatic Recurrent Nonsquamous Non‐Small Cell Lung Cancer

The oncologist (Dayton, Ohio), 2007-06, Vol.12 (6), p.713-718

2007

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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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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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Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

JNCI : Journal of the National Cancer Institute, 2011-04, Vol.103 (8), p.636-644

2011

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U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

Clinical cancer research, 2013-05, Vol.19 (9), p.2289-2293

2013

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Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer

Journal of thoracic oncology, 2018-12, Vol.13 (12), p.1818-1831

2018

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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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FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen

Clinical cancer research, 2017-12, Vol.23 (24), p.7448-7453

2017

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FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

Clinical cancer research, 2017-10, Vol.23 (19), p.5666-5670

2017

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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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Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Comparing Transthoracic versus Transesophageal Echocardiographic Guidance

Journal of the American Society of Echocardiography, 2017-06, Vol.30 (6), p.533-540

2017

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FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

The oncologist (Dayton, Ohio), 2020-07, Vol.25 (7), p.e1077-e1082

2020

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FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer

Clinical cancer research, 2015-12, Vol.21 (23), p.5205-5208

2015

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First FDA Approval Agnostic of Cancer Site — When a Biomarker Defines the Indication

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1

FDA Drug Approval Summary: Bevacizumab (Avastin®) as Treatment of Recurrent Glioblastoma Multiforme

Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

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

FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors

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

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma

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

FDA Drug Approval Summary: Bevacizumab (Avastin®) Plus Carboplatin and Paclitaxel as First‐Line Treatment of Advanced/Metastatic Recurrent Nonsquamous Non‐Small Cell Lung Cancer

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

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

Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer

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

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

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

Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Comparing Transthoracic versus Transesophageal Echocardiographic Guidance

FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer

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