Adnan A. Jaigirdar
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View article: Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer
Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer Open
BACKGROUND: Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), and there remains an unmet clinical need. Bacillus Calmette-Guerin (…
View article: Data from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
Data from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer Open
On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was grante…
View article: Data from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
Data from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology Open
The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE ide…
View article: Data from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
Data from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer Open
On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was grante…
View article: Supplementary Tables S1-S3 from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
Supplementary Tables S1-S3 from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology Open
Supplementary Tables S1-S3
View article: Data from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
Data from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology Open
The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE ide…
View article: Supplementary Tables S1-S3 from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
Supplementary Tables S1-S3 from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology Open
Supplementary Tables S1-S3
View article: Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer Open
Supplementary Table 1 shows adverse reactions occurring at a frequency of 10% or higher in patients with SCLC who received lurbinectedin in Study B-005. Supplementary Table 2 shows select laboratory abnormalities as worsening from baseline…
View article: Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer Open
Supplementary Table 1 shows adverse reactions occurring at a frequency of 10% or higher in patients with SCLC who received lurbinectedin in Study B-005. Supplementary Table 2 shows select laboratory abnormalities as worsening from baseline…
View article: US Food and Drug Administration regulatory updates in neuro-oncology
US Food and Drug Administration regulatory updates in neuro-oncology Open
View article: The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology Open
The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE ide…
View article: FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review Open
On May 26, 2020, the FDA approved nivolumab with ipilimumab and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC), with no EGFR or anaplastic ly…
View article: FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer Open
On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was grante…
View article: A High-avidity WT1-reactive T-Cell Receptor Mediates Recognition of Peptide and Processed Antigen but not Naturally Occurring WT1-positive Tumor Cells
A High-avidity WT1-reactive T-Cell Receptor Mediates Recognition of Peptide and Processed Antigen but not Naturally Occurring WT1-positive Tumor Cells Open
Wilms tumor gene 1 (WT1) is an attractive target antigen for cancer immunotherapy because it is overexpressed in many hematologic malignancies and solid tumors but has limited, low-level expression in normal adult tissues. Multiple HLA cla…