Cargando…

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‐labe...

Descripción completa

Detalles Bibliográficos
Autores principales:	Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	AlphaMed Press 2017
Materias:	Regulatory Issues: FDA
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5344649/ https://www.ncbi.nlm.nih.gov/pubmed/28232599 http://dx.doi.org/10.1634/theoncologist.2016-0476

Ejemplares similares

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy
por: Suzman, Daniel L., et al.
Publicado: (2018)

FDA Approval Summary: Nivolumab for the Treatment of Relapsed or Progressive Classical Hodgkin Lymphoma
por: Kasamon, Yvette L., et al.
Publicado: (2017)

FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy
por: Ning, Yang‐Min, et al.
Publicado: (2017)

FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy
por: Bhatnagar, Vishal, et al.
Publicado: (2017)

FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy
por: Kazandjian, Dickran, et al.
Publicado: (2016)

FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis
por: Kasamon, Yvette L., et al.
Publicado: (2018)

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
por: Larkins, Erin, et al.
Publicado: (2017)

FDA Approval Summary: Brentuximab Vedotin in First‐Line Treatment of Peripheral T‐Cell Lymphoma
por: Richardson, Nicholas C., et al.
Publicado: (2019)

FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation
por: Oneal, Patricia A., et al.
Publicado: (2018)

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
por: Pulte, Elizabeth Dianne, et al.
Publicado: (2018)

FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome
por: Le, Robert Q., et al.
Publicado: (2018)

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1
por: Fashoyin‐Aje, Lola, et al.
Publicado: (2018)

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1
por: Sul, Joohee, et al.
Publicado: (2016)

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond
por: Pai‐Scherf, Lee, et al.
Publicado: (2017)

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations
por: Odogwu, Lauretta, et al.
Publicado: (2018)

FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B‐Cell Acute Lymphoblastic Leukemia
por: Pulte, E. Dianne, et al.
Publicado: (2018)

Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer
por: Kazandjian, Dickran, et al.
Publicado: (2016)

FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation
por: Odogwu, Lauretta, et al.
Publicado: (2017)

Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib
por: Pelosof, Lorraine, et al.
Publicado: (2018)

FDA expedited approval and implications for rational formulary and health plan design
por: Ferries, Erin A, et al.
Publicado: (2021)

China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval
por: Lv, Yunfeng, et al.
Publicado: (2020)

Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer
por: Jarow, Jonathan, et al.
Publicado: (2015)

Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018
por: Rathi, Vinay K, et al.
Publicado: (2023)

Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
por: Rouse, Rodney, et al.
Publicado: (2017)

81007 Training Biomedical Engineers in Regulatory Science: Critical Role of Experts from Industry and FDA
por: Lottes, Aaron E., et al.
Publicado: (2021)

Survey of Japanese Orphan Drug Program: Factors Related to Successful Marketing Approval
por: Harada, Kenji, et al.
Publicado: (2019)

The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With at Least Two Tyrosine Kinase Inhibitors
por: Tesileanu, C Mircea S, et al.
Publicado: (2023)

Regulatory Issues: PMDA – Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma
por: Maruyama, Yoshiaki, et al.
Publicado: (2023)

396 Quantitative Analysis of FDA Warning Letters Related to the Use of Social Media Sites in Product Misbranding for the Treatment, Prevention, or Diagnosis of COVID-19
por: Ajaj, Mahmoud, et al.
Publicado: (2023)

Drug Lag and Key Regulatory Barriers in the Emerging Markets
por: Wileman, Harriet, et al.
Publicado: (2010)

Regulations and guidelines governing stem cell based products: Clinical considerations
por: George, Bobby
Publicado: (2011)

Regulatory Considerations for Biosimilars
por: Nellore, Ranjani
Publicado: (2010)

Registration of Medical Devices
por: George, Bobby
Publicado: (2010)

Implications of ICH-E5: Assessment of drug's sensitivity to ethnic factors and necessity of a bridging study for global drug development
por: Gupta, Sandeep Kumar
Publicado: (2011)

Regulatory requirements for marketing fixed dose combinations
por: Jayasheel, B. G.
Publicado: (2010)

Injury and death in clinical trials and compensation: Rule 122 DAB
por: Ghooi, Ravindra. B.
Publicado: (2013)

Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests
por: Li, Hongran, et al.
Publicado: (2021)

Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
por: Li, Hongran, et al.
Publicado: (2021)

China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents
por: Lv, Yunfeng, et al.
Publicado: (2022)

Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis
por: Mulkey, Flora, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_uj27d4q24t5v30d7d44njqvnp5