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Articles by V. Ellen Mahera
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy
Advertisement Advertisement Daniel L. Suzman (daniel.suzman{at}fda.hhs.gov)*,a, Sundeep Agrawala, Yang‐min Ninga, V. Ellen Mahera, Laura L. Fernandesa, Stella Karuria, Shenghui Tanga, Rajeshwari Sridharaa, Jason Schroedera, Kirsten B. Goldberga, Amna Ibrahima, Amy E. McKeeb, Richard Pazdurb and Julia A.
Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma
Since the accelerated approval of atezolizumab in May 2016 [1], the U.S. Food and Drug Administration (FDA) has approved four additional programmed death receptor?1 (PD?1)/programmed death?ligand 1 (PD?L1) targeted immunotherapies for the treatment of patients with locally advanced or metastatic urothelial cancer. This includes the treatment of patients who have received prior platinum?containing chemotherapy as well as patients who are not eligible for cisplatin?containing chemotherapy.
FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy
Until recently in the United States, no products were approved for second?line treatment of advanced urothelial carcinoma. On May 18, 2016, the U.S. Food and Drug Administration approved atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum?containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum?containing chemotherapy.
FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis
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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