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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: 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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FDA Approval Summary: Ramucirumab for Gastric Cancer

Clinical cancer research, 2015-08, Vol.21 (15), p.3372-3376

2015

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FDA Approval Summary: TAS-102

Clinical cancer research, 2017-06, Vol.23 (12), p.2924-2927

2017

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FDA's Approval of the First Biosimilar to Bevacizumab

Clinical cancer research, 2018-09, Vol.24 (18), p.4365-4370

2018

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FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Clinical cancer research, 2021-04, Vol.27 (7), p.1836-1841

2021

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Tissue-Agnostic Drug Development: A New Path to Drug Approval

Cancer discovery, 2021-09, Vol.11 (9), p.2139-2144

2021

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FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

Clinical cancer research, 2021-09, Vol.27 (17), p.4680-4684

2021

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FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

Clinical cancer research, 2022-07, Vol.28 (13), p.2733-2737

2022

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FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer

Clinical cancer research, 2023-11, Vol.29 (21), p.4326

2023

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FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma

Clinical cancer research, 2024-01, Vol.30 (2), p.269

2024

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FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

Clinical cancer research, 2023-03, Vol.29 (5), p.838-842

2023

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FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease

Clinical cancer research, 2022-12, Vol.28 (24), p.5244-5248

2022

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FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor

Clinical cancer research, 2023-06, Vol.29 (11), p.2020-2024

2023

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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements

Clinical cancer research, 2023-10, Vol.29 (20), p.4027

2023

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Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Clinical cancer research, 2021-11, Vol.27 (21), p.5753-5756

2021

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U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Clinical cancer research, 2010-09, Vol.16 (17), p.4331-4338

2010

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The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Clinical cancer research, 2021-10, Vol.27 (19), p.5161-5167

2021

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Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy

Current oncology reports, 2020-11, Vol.22 (11), p.116-116, Article 116

2020

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Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a Physician's Choice Control Arm in a Randomized Approval Trial

Clinical cancer research, 2012-03, Vol.18 (6), p.1496-1505

2012

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U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

The oncologist (Dayton, Ohio), 2011-01, Vol.16 (1), p.97-104

2011

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When One Is a Hammer, Everything Looks Like a Nail

Journal of oncology practice, 2017-09, Vol.13 (9_suppl), p.10s

Lemery, Steven J

2017

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FDA analysis of grade 3-4 safety events

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.2544-2544

2017

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

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

FDA Approval Summary: Ramucirumab for Gastric Cancer

FDA Approval Summary: TAS-102

FDA's Approval of the First Biosimilar to Bevacizumab

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Tissue-Agnostic Drug Development: A New Path to Drug Approval

FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer

FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease

FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor

FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements

Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration-Melanoma Research Alliance Public Workshop

Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy

Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a Physician's Choice Control Arm in a Randomized Approval Trial

U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

When One Is a Hammer, Everything Looks Like a Nail

FDA analysis of grade 3-4 safety events

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