№ lp_1_2_61985
File format: docx
Character count: 95893
File size: 807 KB
Year:
2019
Region / city:
Australia
Theme:
Oncology, Chemotherapy
Document type:
Resubmission for PBS listing
Organ / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Bristol-Myers Squibb Australia Pty Ltd
Target audience:
Medical professionals, PBAC members
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
Australia
Topic:
Oncology, Urothelial carcinoma, Immunotherapy
Document type:
Medical submission
Organization / Institution:
Bristol-Myers Squibb Australia Pty Ltd
Author:
Unknown
Target audience:
Medical practitioners, healthcare professionals
Period of validity:
Ongoing
Approval date:
2023
Date of amendments:
N/A
Source:
TGA/PBAC Parallel Process
Indication:
First-line treatment for unresectable or metastatic urothelial carcinoma
Treatment phase:
Initial and Continuing treatment
Condition:
Unresectable or metastatic urothelial carcinoma
Treatment criteria:
Patient must meet specific clinical and therapeutic criteria
Year:
2022
Region / City:
Australia
Theme:
Oncology, Medical Treatment
Document Type:
Pharmaceutical Submission
Organization / Institution:
Bristol-Myers Squibb Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, Oncologists
Period of validity:
Ongoing
Approval Date:
4 July 2018
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2021
Region / city:
Australia
Theme:
Cancer treatment
Document type:
Submission for Authority Required listing
Organization / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Bristol-Myers Squibb Australia Pty Ltd
Target audience:
Medical practitioners
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Cancer Treatment / Immunotherapy
Document Type:
Submission
Organ / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Bristol-Myers Squibb
Target Audience:
Medical professionals, healthcare policy makers, pharmaceutical industry stakeholders
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / city:
Australia
Topic:
Oncology / Pharmaceutical
Document Type:
Submission
Agency:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target Audience:
Medical professionals, regulatory authorities
Validity Period:
2021-2026
Approval Date:
20 April 2021
Modification Date:
Not specified
Year:
2023
Region / city:
Australia
Topic:
Vaccination, Immunocompromised individuals, Herpes Zoster
Document type:
Government recommendation
Organization:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
PBAC
Target audience:
Healthcare professionals, Immunocompromised individuals
Period of validity:
From November 1, 2023
Approval date:
November 1, 2023
Modification date:
September 2023
Year:
2019
Region / city:
Australia
Topic:
Adjuvant melanoma treatment
Document type:
Public Summary Document
Organization / institution:
PBAC
Author:
PBAC
Target audience:
Healthcare professionals
Period of validity:
Not specified
Approval date:
July 2019
Date of changes:
July 2019
Year:
2024
Region / City:
Guangzhou, Guangdong Province, China
Topic:
Hepatocellular carcinoma, postoperative radiation therapy
Document Type:
Research article
Organization / Institution:
The Third Affiliated Hospital of Sun Yat-sen University, Qilu Hospital, Shandong University, The First Affiliated Hospital, Guangzhou Medical University
Authors:
Gao-Yuan Yang, Zhi-Wei He, Yong-Chang Tang, Feng Yuan, Ming-Bo Cao, Yu-Peng Ren, Yu-Xuan Li, Xiao-Rui Su, Zhi-Cheng Yao, Mei-Hai Deng
Target Audience:
Medical researchers, clinicians specializing in oncology and hepatobiliary surgery
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Revision:
December 9, 2023
Date of Acceptance:
January 9, 2024
Funding:
The Science and Technology Plan Project of Guangzhou, National Natural Science Foundation Cultivation Project of The Third Affiliated Hospital of Sun Yat-sen University, Natural Science Foundation of Guangdong Province, CSCO-Roche Joint Cancer Research Fund
Year:
2015
Region / City:
Southeastern/Southwest United States
Field:
Medicine, Oncology
Document Type:
Abstract
Organization:
Texas Tech University Health Sciences Center, University of Pennsylvania
Author:
Paul Trippier, Kshitij Verma, Tianzhu Zang, Trevor M. Penning
Target Audience:
Researchers, Medical Professionals
Effective Period:
Not specified
Approval Date:
Not specified
Date of Last Update:
Not specified
Year:
2012
Region / City:
Europe / Vienna
Theme:
Lung Cancer, Oncology
Document Type:
Survey
Organization / Institution:
European Society for Medical Oncology (ESMO)
Author:
Dr. Raffaele Califano
Target Audience:
Medical Oncologists, Radiation Oncologists
Period of Action:
Deadline end of February 2012
Approval Date:
N/A
Date of Changes:
N/A
Year:
2019–2024
Region:
International
Topic:
Oncology / Hepatocellular Carcinoma
Document Type:
Meta-analysis
Institution:
Multiple clinical research centers
Authors:
Various (from included RCTs)
Target Audience:
Medical researchers, oncologists, clinicians
Study Design:
Randomized controlled trials, Phase II and III
Interventions:
Nivolumab, Pembrolizumab, Atezolizumab, Sintilimab
Comparators:
Placebo, standard care, active surveillance
Outcomes Measured:
Overall survival (OS), Recurrence-free survival (RFS), adverse events (AEs)
Sample Size:
Data pooled from 10 studies
Statistical Methods:
DerSimonian-Laird random-effects model, hazard ratios (HRs), risk ratios (RRs)
Adverse Events Reported:
Fatigue, hypertension, elevated liver enzymes (grade 3+)
Publication Type:
Peer-reviewed articles
Description:
Systematic review and meta-analysis of clinical trials assessing survival outcomes and safety of adjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma after curative treatment.
Year:
2021
Institutes:
Walter and Eliza Hall Institute of Medical Research; Peter MacCallum Cancer Centre; University of Melbourne
Authors:
Yat Hang To, Peter Gibbs, Jeanne Tie, Maarten IJzerman, Koen Degeling
Type of document:
Systematic review supplementary material
Subjects:
Colorectal cancer, adjuvant therapy, health economics
Search period:
8th July 2021 – 10th December 2021
Databases searched:
Medline, EMBASE, Health Technology Assessment Database, National Health Service Health Economic Evaluation Database
Language:
English
Corresponding author:
Yat Hang To
ORCID ID:
0000-0002-1497-1700
Email:
[email protected]
Coverage:
Stage II and III colorectal cancer
Year:
2023
Region / City:
Australia
Topic:
Oncology, Urothelial carcinoma, Immunotherapy
Document type:
Medical submission
Organization / Institution:
Bristol-Myers Squibb Australia Pty Ltd
Author:
Unknown
Target audience:
Medical practitioners, healthcare professionals
Period of validity:
Ongoing
Approval date:
2023
Date of amendments:
N/A
Source:
TGA/PBAC Parallel Process
Indication:
First-line treatment for unresectable or metastatic urothelial carcinoma
Treatment phase:
Initial and Continuing treatment
Condition:
Unresectable or metastatic urothelial carcinoma
Treatment criteria:
Patient must meet specific clinical and therapeutic criteria
Year:
2024
Region / City:
Australia
Subject:
Nivolumab and ipilimumab treatment for unresectable malignant mesothelioma
Document type:
Submission report
Organ / Institution:
PBAC, DUSC, TGA
Author:
Unknown
Target audience:
Pharmaceutical regulators, healthcare professionals
Period of validity:
2021-2024
Approval date:
July 2021
Date of changes:
March 2024
Year:
2022
Region / City:
Australia
Theme:
Oncology, Medical Treatment
Document Type:
Pharmaceutical Submission
Organization / Institution:
Bristol-Myers Squibb Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, Oncologists
Period of validity:
Ongoing
Approval Date:
4 July 2018
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2021
Region / city:
Australia
Theme:
Cancer treatment
Document type:
Submission for Authority Required listing
Organization / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Bristol-Myers Squibb Australia Pty Ltd
Target audience:
Medical practitioners
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Cancer Treatment / Immunotherapy
Document Type:
Submission
Organ / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Bristol-Myers Squibb
Target Audience:
Medical professionals, healthcare policy makers, pharmaceutical industry stakeholders
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2019
Region / city:
Australia
Topic:
Adjuvant melanoma treatment
Document type:
Public Summary Document
Organization / institution:
PBAC
Author:
PBAC
Target audience:
Healthcare professionals
Period of validity:
Not specified
Approval date:
July 2019
Date of changes:
July 2019
Year:
2025
Region / Country:
United States
Subject:
Oncology / Immunotherapy
Document Type:
Patient Educational Material
Organization:
National Cancer Institute (NCI)
Intended Audience:
Research staff, clinical trial participants
Version Date:
December 5, 2025
Drug Names:
Nivolumab, Relatlimab (Opdualag)
Side Effect Categories:
Common, Occasional, Rare
Clinical Trial Networks:
CTEP-supported US sites
Regulatory Note:
Not approved by NCI CIRB as patient information sheet for trials
Year:
2026
Study type:
Immunology / Oncology
Document type:
Supplementary material
Institution:
Research laboratory or medical center
Methods:
Flow cytometry, 16S rRNA sequencing
Subjects:
Tumor-infiltrating lymphocytes and peripheral blood mononuclear cells
Treatment:
Chemoradiotherapy followed by nivolumab
Markers analyzed:
CD8+, CD4+, Ki-67, CTLA-4
Sample type:
Tumor tissue and stool
Period of study:
Pre- and post-chemoradiotherapy
Audience:
Scientific community