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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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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: Ramucirumab for Gastric Cancer

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

2015

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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.4326-4330

2023

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FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer

Clinical cancer research, 2024-08, Vol.30 (16), p.3371-3377

2024

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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: 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.4027-4031

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: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

Clinical cancer research, 2024-08, Vol.30 (15), p.3100-3104

2024

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The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative

Clinical cancer research, 2016-05, Vol.22 (9), p.2111-2113

2016

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Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma

JHEP reports, 2023-06, Vol.5 (6), p.100747-100747, Article 100747

2023

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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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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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Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.4115-4115

2023

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FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.4117-4117

2023

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FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib

The oncologist (Dayton, Ohio), 2021-09, Vol.26 (9), p.797-806

2021

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Experience with chemoreduction and focal therapy for intraocular retinoblastoma in a developing country

Pediatric blood & cancer, 2005-05, Vol.44 (5), p.455-460

2005

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Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study

Clinical cancer research, 2016-11, Vol.22 (21), p.5167-5170

2016

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Antibiotic therapy and association with oncological outcomes from targeted and immune-based therapy in hepatocellular carcinoma (HCC)

Journal of clinical oncology, 2022-06, Vol.40 (16_suppl), p.4089-4089

2022

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Benefit–Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine‐ and Platinum‐Based Chemotherapy

The oncologist (Dayton, Ohio), 2021-04, Vol.26 (4), p.318-324

2021

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Paediatric oncology in Argentina: medical and ethical issues

The lancet oncology, 2002-02, Vol.3 (2), p.111-117

2002

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Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib

The oncologist (Dayton, Ohio), 2018-04, Vol.23 (4), p.496-500

2018

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FDA analysis of the characteristics and relevance of serious adverse events that are Grade 1 or 2 in severity

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.2538-2538

2016

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Characteristics of breakthrough therapy designation requests (BTDRs) submitted to the Office of Hematology and Oncology Products (OHOP), FDA

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.e18236-e18236

2017

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

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: Ramucirumab for Gastric Cancer

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

FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer

FDA's Approval of the First Biosimilar to Bevacizumab

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

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

FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative

Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma

FDA analysis of grade 3-4 safety events

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

Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals

FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma

FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib

Experience with chemoreduction and focal therapy for intraocular retinoblastoma in a developing country

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study

Antibiotic therapy and association with oncological outcomes from targeted and immune-based therapy in hepatocellular carcinoma (HCC)

Benefit–Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine‐ and Platinum‐Based Chemotherapy

Paediatric oncology in Argentina: medical and ethical issues

Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib

FDA analysis of the characteristics and relevance of serious adverse events that are Grade 1 or 2 in severity

Characteristics of breakthrough therapy designation requests (BTDRs) submitted to the Office of Hematology and Oncology Products (OHOP), FDA

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