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Gideon M. Blumenthal

Center for Drug Evaluation and Research

41

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Leveraging the Success of HIV Drug Development Paradigms for Cancer

2018 Clinical Cancer Research
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FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

2018 Clinical Cancer Research
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U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer

2018 Clinical Cancer Research
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Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer.

2018 Journal of Thoracic Oncology
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Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis

2018 Lancet Oncology
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A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Multiple Myeloma

2018 Clinical Pharmacology & Therapeutics
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Considerations for Developing Targeted Therapies in Low‐Frequency Molecular Subsets of a Disease

2018 Clinical Pharmacology & Therapeutics
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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy

2018 Clinical Cancer Research
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Setting the Record Straight on FDA Approvals in Oncology

2017 JAMA Internal Medicine
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FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy

2017 Oncologist
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