№ lp_1_19628
File format: docx Character count: 86342 File size: 503 KB
This document presents a resubmission request for the listing of acalabrutinib as a treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma in combination with obinutuzumab, addressing previous PBAC concerns.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

Don’t have cryptocurrency yet?

You can still complete your purchase in a few minutes:
  1. Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
  2. In the app, tap Send.
  3. Select network, paste our wallet address.
  4. Send the exact amount shown above.
After sending, paste your TXID (transaction ID) and your email to receive the download link. Need help? Contact support and we’ll guide you step by step.

The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
A phase II trial of Bendamustine, Rituximab and Acalabrutinib in previously untreated Waldenström’s Macroglobulinemia (BRAWM)
Year: 2024
Country: Canada
Study Type: Phase II clinical trial
Treatment Regimen: Bendamustine-Rituximab combination with concurrent Acalabrutinib
Participants: 62
Centers: 9
Primary Endpoint: Combined Complete and Very Good Partial Response (CR+VGPR) rates
Secondary Endpoints: Best overall response (BoR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), Minimal Residual Disease (MRD)
Median Age: 69
Mutation Analysis: MYD88 89.3%, CXCR4 28.6%, TP53 1.8%
Adverse Events: Treatment-related adverse events (TRAEs) in 53 participants, 42 Grade 3/4 during combination therapy, 15 Grade 3/4 during monotherapy
Follow-up: Median 350 days
Data Cut-off: June 5, 2024
Document Type: Clinical trial report
Purpose of resubmission The standard re-entry resubmission requested an Authority Required General Schedule listing of acalabrutinib, for use in combination with obinutuzumab, for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), who are considered unsuitable for treatment with fludarabine-based chemoimmunotherapy.
Year: 2023
Region / city: Australia
Topic: Oncology, Pharmaceuticals
Document Type: Resubmission
Institution: Australian Government, Pharmaceutical Benefits Advisory Committee
Author: AstraZeneca Pty Ltd.
Target Audience: Healthcare professionals, regulatory bodies
Effective Period: Ongoing
Approval Date: November 2021
Date of Changes: November 2021
DAPAGLIFLOZIN AND METFORMIN XR (FDC), modified release tablets, 10 mg/500 mg, 10 mg/1000 mg, 5 mg/1000 mg, Xigduo XR®, AstraZeneca Pty Ltd
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
OSIMERTINIB, Tablet 40 mg, Tablet 80 mg, Tagrisso®, ASTRAZENECA PTY LTD
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
Osimertinib, Tablet 40 mg, Tablet 80 mg, Tagrisso®, AstraZeneca Pty Ltd
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.
TRASTUZUMAB DERUXTECAN, Powder for I.V. infusion 100 mg, Enhertu®, ASTRAZENECA PTY LTD
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
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: Calquence Acalabrutinib AstraZeneca