№ lp_1_2_23197
File format: docx Character count: 89516 File size: 504 KB
This is a submission document requesting the listing of trastuzumab deruxtecan for the treatment of metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma on the Australian Pharmaceutical Benefits Scheme (PBS).
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
TRASTUZUMAB DERUXTECAN, Powder for I.V. infusion 100 mg, Enhertu®, ASTRAZENECA PTY LTD
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.
TRASTUZUMAB DERUXTECAN, Powder for I.V. infusion 100 mg, Enhertu®, ASTRAZENECA PTY LTD
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.
Possible Side Effects of Trastuzumab (Table Version Date: June 14, 2024)
Year: 2024
Region / city: USA
Topic: Medical, Oncology
Document Type: Educational Materials
Organization: NCI CIRB
Author: NCI
Target Audience: Research staff, IRB members, clinical trial participants
Period of Validity: Not specified
Approval Date: Not specified
Date of Changes: Not specified
TRASTUZUMAB DERUXTECAN, Powder for I.V. infusion 100 mg, Enhertu®, ASTRAZENECA PTY LTD
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.
Topics: DERUXTECAN Enhertu Trastuzumab