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Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis.
- Published in:
- JNCI: Journal of the National Cancer Institute, 2024, v. 116, n. 7, p. 1043, doi. 10.1093/jnci/djae066
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- Publication type:
- Article
FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity.
- Published in:
- Clinical Lymphoma, Myeloma & Leukemia, 2023, v. 23, n. 6, p. 463, doi. 10.1016/j.clml.2023.03.012
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- Publication type:
- Article
FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.
- Published in:
- Pediatric Blood & Cancer, 2022, v. 69, n. 8, p. 1, doi. 10.1002/pbc.29602
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- Publication type:
- Article
FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy.
- Published in:
- Oncologist, 2022, v. 27, n. 6, p. 493, doi. 10.1093/oncolo/oyac042
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- Publication type:
- Article
Impact of an evolving regulatory landscape on skin cancer drug development in the United States.
- Published in:
- Dermatology Online Journal, 2022, v. 28, n. 2, p. 1, doi. 10.5070/D328257391
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- Publication type:
- Article
FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial.
- Published in:
- Oncologist, 2022, v. 27, n. 2, p. 149, doi. 10.1093/oncolo/oyab040
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- Publication type:
- Article
FDA Approval Summary: Selinexor for Relapsed or Refractory Diffuse Large B‐Cell Lymphoma.
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- Oncologist, 2021, v. 26, n. 10, p. 879, doi. 10.1002/onco.13859
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- Publication type:
- Article
Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health.
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- Oncologist, 2021, v. 26, n. 10, p. e1786, doi. 10.1002/onco.13887
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- Publication type:
- Article
Oncology Expanded Access and FDA's Project Facilitate.
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- Oncologist, 2021, v. 26, n. 10, p. e1880, doi. 10.1002/onco.13910
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- Publication type:
- Article
FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib.
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- Oncologist, 2021, v. 26, n. 9, p. 797, doi. 10.1002/onco.13819
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- Publication type:
- Article
US Food and Drug Administration regulatory updates in neuro-oncology.
- Published in:
- Journal of Neuro-Oncology, 2021, v. 153, n. 3, p. 375, doi. 10.1007/s11060-021-03789-5
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- Publication type:
- Article
FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum‐Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.
- Published in:
- Oncologist, 2021, v. 26, n. 5, p. 433, doi. 10.1002/onco.13752
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- Publication type:
- Article
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.
- Published in:
- Oncologist, 2021, v. 26, n. 4, p. 318, doi. 10.1002/onco.13646
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- Publication type:
- Article
FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma.
- Published in:
- Oncologist, 2021, v. 26, n. 3, p. e484, doi. 10.1002/onco.13566
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- Publication type:
- Article
FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer.
- Published in:
- Oncologist, 2021, v. 26, n. 1, p. e164, doi. 10.1002/onco.13551
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- Publication type:
- Article
FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients.
- Published in:
- Pediatric Blood & Cancer, 2020, v. 67, n. 12, p. 1, doi. 10.1002/pbc.28688
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- Publication type:
- Article
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy.
- Published in:
- Current Oncology Reports, 2020, v. 22, n. 11, p. N.PAG, doi. 10.1007/s11912-020-00974-z
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- Publication type:
- Article
FDA Oncology Center of Excellence Review Processes and Tools.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 3, p. 428, doi. 10.1002/cpt.1945
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- Publication type:
- Article
FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma.
- Published in:
- Oncologist, 2020, v. 25, n. 7, p. e1077, doi. 10.1634/theoncologist.2020-0184
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- Publication type:
- Article
Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.
- Published in:
- Oncologist, 2020, v. 25, n. 4, p. 348, doi. 10.1634/theoncologist.2019-0653
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- Publication type:
- Article
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 3, p. 495, doi. 10.1002/cpt.1589
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- Publication type:
- Article
An Analysis of Recent FDA Oncology Scientific Publications.
- Published in:
- Oncologist, 2020, v. 25, n. 3, p. 266, doi. 10.1634/theoncologist.2019-0503
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- Publication type:
- Article
FDA Approval Summary: Ruxolitinib for Treatment of Steroid‐Refractory Acute Graft‐Versus‐Host Disease.
- Published in:
- Oncologist, 2020, v. 25, n. 2, p. e328, doi. 10.1634/theoncologist.2019-0627
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- Publication type:
- Article
Real-world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non-small cell lung cancer.
- Published in:
- 2019
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- Publication type:
- journal article
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 123, doi. 10.1002/cpt.1461
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- Publication type:
- Article
Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.
- Published in:
- 2019
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- Publication type:
- journal article
Real‐World Outcomes of Patients with Metastatic Non‐Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.
- Published in:
- Oncologist, 2019, v. 24, n. 5, p. 648, doi. 10.1634/theoncologist.2018-0307
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- Publication type:
- Article
FDA Approval Summary: Brentuximab Vedotin in First‐Line Treatment of Peripheral T‐Cell Lymphoma.
- Published in:
- Oncologist, 2019, v. 24, n. 5, p. e180, doi. 10.1634/theoncologist.2019-0098
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- Publication type:
- Article
U.S. Food and Drug Administration Benefit‐Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission.
- Published in:
- Oncologist, 2019, v. 24, n. 5, p. e188, doi. 10.1634/theoncologist.2018-0759
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- Publication type:
- Article
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy.
- Published in:
- Oncologist, 2019, v. 24, n. 4, p. 563, doi. 10.1634/theoncologist.2018-0084
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- Publication type:
- Article
FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1.
- Published in:
- Oncologist, 2019, v. 24, n. 1, p. 103, doi. 10.1634/theoncologist.2018-0221
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- Publication type:
- Article
FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis.
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- Oncologist, 2018, v. 23, n. 12, p. 1511, doi. 10.1634/theoncologist.2018-0222
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- Publication type:
- Article
FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation.
- Published in:
- Oncologist, 2018, v. 23, n. 12, p. 1520, doi. 10.1634/theoncologist.2018-0295
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- Publication type:
- Article
FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B‐Cell Acute Lymphoblastic Leukemia.
- Published in:
- Oncologist, 2018, v. 23, n. 11, p. 1366, doi. 10.1634/theoncologist.2018-0179
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- Publication type:
- Article
FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33‐Positive Acute Myeloid Leukemia.
- Published in:
- Oncologist, 2018, v. 23, n. 9, p. 1103, doi. 10.1634/theoncologist.2017-0604
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- Publication type:
- Article
FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome.
- Published in:
- Oncologist, 2018, v. 23, n. 8, p. 943, doi. 10.1634/theoncologist.2018-0028
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- Publication type:
- Article
FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma.
- Published in:
- Oncologist, 2018, v. 23, n. 6, p. 734, doi. 10.1634/theoncologist.2017-0440
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- Publication type:
- Article
FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations.
- Published in:
- Oncologist, 2018, v. 23, n. 6, p. 740, doi. 10.1634/theoncologist.2017-0642
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- Publication type:
- Article
Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.
- Published in:
- Oncologist, 2018, v. 23, n. 4, p. 496, doi. 10.1634/theoncologist.2017-0422
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- Publication type:
- Article
Characteristics of Real‐World Metastatic Non‐Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.
- Published in:
- Oncologist, 2018, v. 23, n. 3, p. 328, doi. 10.1634/theoncologist.2017-0353
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- Publication type:
- Article
FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.
- Published in:
- Oncologist, 2018, v. 23, n. 3, p. 353, doi. 10.1634/theoncologist.2017-0425
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- Publication type:
- Article
The FDA Oncology Center of Excellence and precision medicine.
- Published in:
- Experimental Biology & Medicine, 2018, v. 243, n. 3, p. 308, doi. 10.1177/1535370217740861
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- Publication type:
- Article
Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.
- Published in:
- 2018
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- Publication type:
- Editorial
A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 1, p. 67, doi. 10.1002/cpt.871
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- Publication type:
- Article
U.S. Food and Drug Administration approval summary: Eltrombopag for the treatment of pediatric patients with chronic immune (idiopathic) thrombocytopenia.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Real-world Data for Clinical Evidence Generation in Oncology.
- Published in:
- 2017
- By:
- Publication type:
- journal article
FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
- Published in:
- Oncologist, 2017, v. 22, n. 11, p. 1347, doi. 10.1634/theoncologist.2017-0229
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- Publication type:
- Article
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.
- Published in:
- Oncologist, 2017, v. 22, n. 11, p. 1392, doi. 10.1634/theoncologist.2017-0078
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- Publication type:
- Article
Setting the Record Straight on FDA Approvals in Oncology.
- Published in:
- 2017
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- Publication type:
- journal article
Regulatory considerations on endpoints in ovarian cancer drug development.
- Published in:
- 2017
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- Publication type:
- journal article