Robert Q. Le
YOU?
Author Swipe
View article: Supplementary Table S3 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S3 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Efficacy endpoint definitions
View article: Supplementary Table S4 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S4 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Hypersensitivity reactions
View article: Supplementary Figure S1 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Figure S1 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Exposure-response graphs for efficacy outcomes
View article: Supplementary Figure S3 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Figure S3 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
A subgroup Forest plot for efficacy outcomes
View article: Supplementary Table S6 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S6 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Selected AESI by dosage
View article: Supplementary Table S7 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S7 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Grouped terms used for adverse reactions
View article: Supplementary Table S2 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S2 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
The incidences of treatment-related adverse reactions by dosage
View article: Supplementary Figure S4 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Figure S4 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Graphs of time to AESIs
View article: Supplementary Table S5 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S5 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
The incidences of infections by dosage
View article: Supplementary Table S1 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Table S1 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Efficacy outcomes by dosage.
View article: Data from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Data from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
On August 14, 2024, the FDA approved axatilimab, a colony-stimulating factor-1 receptor–blocking antibody, for chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 …
View article: Supplementary Figure S2 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy
Supplementary Figure S2 from FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy Open
Exposure-response graphs for safety outcomes
View article: FDA Analysis of Race and Ethnic Enrollment of Clinical Trials for Drug Registration in Adult Patients for Leukemia and Myelodysplastic Syndrome
FDA Analysis of Race and Ethnic Enrollment of Clinical Trials for Drug Registration in Adult Patients for Leukemia and Myelodysplastic Syndrome Open
Introduction: Underrepresentation of racial and ethnic minorities in cancer clinical trials is a well-documented issue and contributes to disparities in outcomes. Despite greater awareness and development of initiatives to increase diversi…
View article: Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy Open
On July 16, 2021, the FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD (cGvHD) after failure of at least two prior lines of systemic therapy. Approval was based on the resu…
View article: Supplementary Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
Supplementary Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy Open
Supplementary Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
View article: Supplementary Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
Supplementary Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy Open
Supplementary Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
View article: Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
Data from FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy Open
On July 16, 2021, the FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD (cGvHD) after failure of at least two prior lines of systemic therapy. Approval was based on the resu…
View article: FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy
FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy Open
On September 22, 2021, the Food and Drug Administration approved ruxolitinib for the treatment of chronic graft-versus-host disease (cGVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years …
View article: FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy Open
On July 16, 2021, the FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD (cGvHD) after failure of at least two prior lines of systemic therapy. Approval was based on the resu…
View article: Framingham Risk Score Is an Ineffective Screening Strategy for Coronary Heart Disease in Long-Term Allogeneic Hematopoietic Cell Transplant Survivors
Framingham Risk Score Is an Ineffective Screening Strategy for Coronary Heart Disease in Long-Term Allogeneic Hematopoietic Cell Transplant Survivors Open
Long-term allogeneic hematopoietic cell transplant (allo-HCT) survivors suffer an elevated risk of coronary heart disease (CHD). We conducted a prospective, nonrandomized, cross-sectional study to screen asymptomatic survivors at a single …
View article: FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome
FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome Open
On August 30, 2017, the U.S. Food and Drug Administration approved Actemra (tocilizumab, Genentech, Inc., South San Francisco, CA) for the treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine rele…
View article: Tocilizumab for Treatment of Severe or Life-Threatening Chimeric Antigen Receptor T Cell-Induced Cytokine Release Syndrome—FDA Approval Summary
Tocilizumab for Treatment of Severe or Life-Threatening Chimeric Antigen Receptor T Cell-Induced Cytokine Release Syndrome—FDA Approval Summary Open
On August 30, 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS) in adults and in pediatric patien…
View article: National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Immune Dysregulation and Pathobiology Working Group Report
National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Immune Dysregulation and Pathobiology Working Group Report Open
Immune reconstitution after hematopoietic stem cell transplantation (HCT) beyond 1 year is not completely understood. Many transplant recipients who are free of graft-versus-host disease (GVHD) and not receiving any immunosuppression more …
View article: Minor ABO Incompatibility Does Not Impact Nonrelapse Mortality in T Cell–Depleted Human Leukocyte Antigen–Matched Sibling Transplantation
Minor ABO Incompatibility Does Not Impact Nonrelapse Mortality in T Cell–Depleted Human Leukocyte Antigen–Matched Sibling Transplantation Open
ABO incompatibility (ABO-I) is known to produce hemolytic complications including acute hemolysis, passenger lymphocyte syndrome, delayed transfusion dependence, and pure red cell aplasia [1Booth G.S. Gehrie E.A. Bolan C.D. Savani B.N. Cli…
View article: Minor ABO Incompatibility Does Not Impact Non-Relapse Mortality in T-Cell Depleted HLA-Matched Sibling Transplantation
Minor ABO Incompatibility Does Not Impact Non-Relapse Mortality in T-Cell Depleted HLA-Matched Sibling Transplantation Open
ABO incompatibility (ABO-I) in allogeneic stem cell transplantation is known to produce hemolytic complications including acute hemolysis, the passenger lymphocyte syndrome, delayed transfusion dependence and pure red cell aplasia. Hemolys…
View article: Blood Stream Infection Is Frequent during Conditioning but Does Not Impact Allogeneic Transplant Outcomes in the Modern Era
Blood Stream Infection Is Frequent during Conditioning but Does Not Impact Allogeneic Transplant Outcomes in the Modern Era Open
Bacteremia occurs frequently in the neutropenic period of early allogeneic stem cell transplantation (SCT). Effective strategies have been developed for the rapid diagnosis and management of bacteremia in immunocompromised SCT recipients. …
View article: Bone Mineral Density (BMD) Improves in Survivors in Their Second Decade Post-Allogeneic Stem Cell Transplantation and Is Influenced By Body Mass Index (BMI) and Age
Bone Mineral Density (BMD) Improves in Survivors in Their Second Decade Post-Allogeneic Stem Cell Transplantation and Is Influenced By Body Mass Index (BMI) and Age Open
Rapid and profound BMD loss occur in the first year after allogeneic stem cell transplantation (SCT) and attributed to steroid exposure, chronic GVHD (cGVHD), conditioning, age and gender. However, changes in BMD in very long-term survivor…