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V. Ellen Maher

As seen in: The Oncologist
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Articles by V. Ellen Maher

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody | Journal of Clinical Oncology

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By V. Ellen Maher, Laura Fernandes, Chana Weinstock, Shenghui Tang
| ascopubs.org
Five monoclonal antibodies directed against programmed death protein 1 (PD-1) or programmed death protein ligand 1 (PD-L1) have been approved in the United States for the treatment of advanced or metastatic urothelial cancer. All have been approved for the treatment of patients who received prior platinum-based therapy, and two were also approved for the treatment of patients who are cisplatin ineligible.
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FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis

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By V. Ellen Mahera, Geoffrey Kima, James Xunhai Xu, V. Ellen Maher
| The Oncologist Verified
On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO, Bristol?Myers Squibb Company) for patients with advanced renal cell carcinoma (RCC) who have received prior anti?angiogenic therapy. The approval was based on efficacy and safety data demonstrated in an open?label, randomized study of 821 patients with advanced RCC who progressed after at least one anti?angiogenic therapy. Patients were randomized to nivolumab or everolimus and followed for disease progression.
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