Marc R. Theoret
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View article: Supplementary Table S2: Summary of Crowdsourcing Sumbissions Received from FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data
Supplementary Table S2: Summary of Crowdsourcing Sumbissions Received from FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data Open
Summary of Crowdsourcing Submissions Received
View article: Supplementary Table S1: Pooled analyses of oncology clinical trial data 2018-2021 from FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data
Supplementary Table S1: Pooled analyses of oncology clinical trial data 2018-2021 from FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data Open
Pooled analyses of oncology clinical trial data 2018-2021
View article: Machine learning reveals distinct T-cell receptor clusters in plasma cell dyscrasias compared to healthy controls
Machine learning reveals distinct T-cell receptor clusters in plasma cell dyscrasias compared to healthy controls Open
T-cell receptor (TCR) repertoire diversity has been implicated in the progression and prognosis of multiple myeloma (MM). This study aimed to evaluate the association between T-cell clonality, immune response, and clinical outcomes in pati…
View article: Supplementary Table S2 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S2 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S2 shows the p-values for overall survival and relapse-free survival across the three randomized studies.
View article: Supplementary Figure S1 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Figure S1 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Figure S1 shows the E1910 Trial Design, including randomization scheme and phases of therapy.
View article: Supplementary Table S4 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S4 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S4 shows the demographics of the randomized populations for the HR/IR and LR cohorts in Study AALL1331
View article: Supplementary Figure S3 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Figure S3 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Figure S3 shows the AALL1331 study design for both the high/intermediate risk and low risk cohorts.
View article: Supplementary Table S3 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S3 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S3 shows the demographics of the randomized population for Study 20120215.
View article: Supplementary Table S1 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S1 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S1 shows the demographics of the randomized, MRD-negative cohort from Study E1910.
View article: Data from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Data from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
On June 14, 2024, the FDA approved blinatumomab (BLINCYTO; Amgen, Inc.) in the consolidation phase of treatment for CD19-positive, Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia (BCP ALL). The FDA reviewed r…
View article: Supplementary Figure S5 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Figure S5 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Figure S5 shows the steady state concentrations of blinatumomab in adult and pediatric patients with R/R BCP ALL by weight (a) and age(b) subgroups.
View article: Supplementary Table S5 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S5 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S5 shows the Grouped Terms used for the safety analyses for Studies E1910, 20120215, and AALL1331.
View article: Supplementary Figure S2 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Figure S2 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Figure S2 shows the Study 20120215 Study Design, including the pre-randomization chemotherapy cycles.
View article: Supplementary Figure S4 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Figure S4 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Figure S4 shows the NL.599071.078.17 study design.
View article: Supplementary Table S7 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S7 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S7 enumerates the indications granted by other regulatory agencies for blinatumomab in the consolidation phase of therapy for BCP ALL.
View article: Supplementary Table S6 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Table S6 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Table S6 shows the adverse events of special interest, including cytokine release syndrome, neurologic toxicities, and infectious complications across the randomized studies
View article: Supplementary Figure S6 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy
Supplementary Figure S6 from FDA Approval Summary: Blinatumomab for the Treatment of B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy Open
Figure S6 shows the FDA meta-analysis results for the overall survival endpoint across the three randomized studies (E1910, 20120215, AALL1331) and the literature study.
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 S1 from FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an <i>IDH1</i> Mutation
Supplementary Table S1 from FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an <i>IDH1</i> Mutation Open
Response by IDH1 Subtype
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 S2 from FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an <i>IDH1</i> Mutation
Supplementary Table S2 from FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an <i>IDH1</i> Mutation Open
Frequent Laboratory Abnormalities
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: Supplementary Table S3 from FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an <i>IDH1</i> Mutation
Supplementary Table S3 from FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an <i>IDH1</i> Mutation Open
Preferred Terms