№ lp_1_2_23195
File format: docx
Character count: 88668
File size: 587 KB
Year:
2024
Region / City:
Australia
Topic:
Pharmaceutical Submission, Oncology
Document Type:
Submission for Pharmaceutical Benefits Scheme (PBS) Listing
Organ / Institution:
Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target Audience:
Healthcare Professionals, Medical Practitioners
Period of Effectiveness:
Ongoing (starting 30 October 2024)
Approval Date:
30 October 2024
Date of Changes:
2 December 2024
Clinical Criteria:
First-line treatment, Locally advanced or metastatic NSCLC, EGFR mutations
Indication:
Locally advanced (Stage IIIB/C) or metastatic (Stage IV) EGFRm non-small cell lung cancer
Drug Formulation:
Osimertinib combined with cisplatin or carboplatin and pemetrexed
Treatment Phase:
Initial treatment (first-line)
Comparator:
Osimertinib monotherapy
Outcome Measures:
PFS, OS, ORR, DoR, DCR
Background:
TGA approval for osimertinib combination therapy for EGFRm NSCLC
Preliminary PBAC Consideration:
Not previously considered for this indication
Requested Listing:
Authority Required Pharmaceutical Benefits Scheme listing
Context:
A pharmaceutical submission for the listing of osimertinib in combination with platinum-based chemotherapy and pemetrexed for first-line treatment of EGFR-mutated non-small cell lung cancer in Australia.
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Year:
2024
Region / city:
Australia
Topic:
Oncology, Pharmaceutical Submission
Document Type:
Submission for Pharmaceutical Listing
Organ / institution:
Therapeutic Goods Administration (TGA)
Author:
Unknown
Target Audience:
Medical Practitioners, Regulatory Authorities
Period of Validity:
N/A
Approval Date:
November 28, 2024
Date of Last Revision:
N/A
Year:
2024
Region / city:
Australia
Topic:
Oncology, Pharmaceutical Submission
Document Type:
Submission for Pharmaceutical Listing
Organ / institution:
Therapeutic Goods Administration (TGA)
Author:
Unknown
Target Audience:
Medical Practitioners, Regulatory Authorities
Period of Validity:
N/A
Approval Date:
November 28, 2024
Date of Last Revision:
N/A
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:
Oncology, Pharmaceutical Submission
Document Type:
Pharmaceutical Resubmission
Organization:
AstraZeneca Pty Ltd
Author:
Not specified
Target Audience:
Medical Practitioners
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A pharmaceutical resubmission document outlining the use of osimertinib as a first-line treatment for locally advanced or metastatic EGFRm non-small cell lung cancer (NSCLC) in Australia, including previous PBAC considerations and clinical trial data.
Medication:
Osimertinib
Table Version Date:
December 5, 2025
Subject:
Adverse effects of cancer therapy
Document Type:
Side effect reference table
Field:
Oncology
Related Clinical Context:
Clinical trials involving standard cancer therapies
Organization Mentioned:
National Cancer Institute (NCI)
Program:
Cancer Therapy Evaluation Program (CTEP)
Review Body Mentioned:
NCI Central Institutional Review Board (CIRB)
Country:
United States
Intended Users:
Research staff
Associated Platform:
Clinical Trials Support Unit (CTSU) protocol pages
Purpose:
Reference information on potential adverse reactions during treatment
Content Structure:
Common, occasional, and rare side effects with approximate frequency ranges
Regulatory Note:
Not approved by NCI CIRB as a patient information sheet unless reviewed by the IRB of record
Year:
2023
Region / city:
Australia
Theme:
Oncology, Chronic Lymphocytic Leukaemia
Document Type:
Resubmission Report
Organization:
AstraZeneca Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, healthcare policymakers
Period of validity:
Not specified
Approval Date:
November 2019
Date of Changes:
December 2022
Year:
2014
Region / city:
Australia
Topic:
Pharmaceutical product submission
Document type:
Application for listing
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Health professionals, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
1 April 2014
Year:
2024
Region / city:
Australia
Topic:
Oncology, Pharmaceutical Submission
Document Type:
Submission for Pharmaceutical Listing
Organ / institution:
Therapeutic Goods Administration (TGA)
Author:
Unknown
Target Audience:
Medical Practitioners, Regulatory Authorities
Period of Validity:
N/A
Approval Date:
November 28, 2024
Date of Last Revision:
N/A
Year:
2025
Region / city:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission for PBS listing
Organ / institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Medical Services Advisory Committee (MSAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Medical professionals, healthcare policy makers
Effective period:
2025 onward
Approval date:
March 25, 2025
Date of changes:
September 10, 2024
Year:
2023
Region / City:
Australia
Topic:
Oncology, Drug Approval
Document Type:
Submission for Pharmaceutical Listing
Organization:
ASTRAZENECA PTY LTD
Author:
Unknown
Target Audience:
Healthcare professionals, regulatory bodies, oncology specialists
Effective Period:
2023
Approval Date:
January 2023
Modification Date:
Not specified
Treatment:
Trastuzumab deruxtecan (T-DXd)
Indication:
Unresectable and/or metastatic HER2-low breast cancer
Comparator:
Physician’s choice of chemotherapy, Sacituzumab govitecan
Outcome Metrics:
Overall survival, Progression-free survival, Objective response rate, Duration of response, Time to progression, Quality of life, Safety
Clinical Claim:
T-DXd demonstrates superior efficacy for HR positive/HER2-low BC, and non-inferior efficacy for HR negative/HER2-low BC, compared to other treatments.
Source:
Table 1-1, p47 of the submission.