№ lp_1_2_37086
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This document is a resubmission request to the Pharmaceutical Benefits Advisory Committee (PBAC) seeking the inclusion of venetoclax (VTX) with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia (AML), ineligible for standard intensive chemotherapy.
Year: 2021
Region / city: Australia
Topic: Pharmaceutical Drug Submission
Document type: Resubmission Request
Organization / institution: PBAC
Author: AbbVie Pty Ltd.
Target audience: Healthcare professionals, PBAC
Validity period: Not specified
Approval date: 2021
Date of amendments: Not specified
Price: 8 / 10 USD
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PBS Section 85 Authority Required Listing Submission for Venetoclax (Venclexta®) for Relapsed/Refractory Chronic Lymphocytic Leukaemia, 2016–2017
Medicine: Venetoclax
Brand name: Venclexta®
Sponsor: AbbVie Pty Ltd
Dosage forms: Tablets 10 mg, 50 mg, 100 mg
Pack types: Titration pack; Dose hold packs; Maintenance pack
Regulatory authority: Pharmaceutical Benefits Advisory Committee (PBAC)
Regulatory process: TGA/PBAC Parallel Process
ARTG registration date: 5 January 2017
Requested listing: Section 85 Authority Required (PBS)
Indication: Relapsed/refractory chronic lymphocytic leukaemia (CLL)
Patient subgroup: 17p deletion and/or TP53 mutation; highly refractory disease
Comparator: Ofatumumab monotherapy; Rituximab monotherapy
Related assessments: MSAC streamlined co-dependent assessment pathway
Clinical context: Second- and third-line therapy in relapsed/refractory CLL
Document type: PBS listing submission summary
Supplementary methods Assay parameters and performance of venetoclax and voriconazole
Note: Year
Subject: Pharmacology
Document type: Research methodology
Target audience: Researchers, Pharmacologists
Description: This document provides the experimental setup, assay parameters, and performance data for the analysis of venetoclax and voriconazole in a pharmacokinetic study.
PBS Section 85 Authority Required Listing Submission for Venetoclax (Venclexta®) for Relapsed/Refractory Chronic Lymphocytic Leukaemia, 2016–2017
Medicine: Venetoclax
Brand name: Venclexta®
Sponsor: AbbVie Pty Ltd
Dosage forms: Tablets 10 mg, 50 mg, 100 mg
Pack types: Titration pack; Dose hold packs; Maintenance pack
Regulatory authority: Pharmaceutical Benefits Advisory Committee (PBAC)
Regulatory process: TGA/PBAC Parallel Process
ARTG registration date: 5 January 2017
Requested listing: Section 85 Authority Required (PBS)
Indication: Relapsed/refractory chronic lymphocytic leukaemia (CLL)
Patient subgroup: 17p deletion and/or TP53 mutation; highly refractory disease
Comparator: Ofatumumab monotherapy; Rituximab monotherapy
Related assessments: MSAC streamlined co-dependent assessment pathway
Clinical context: Second- and third-line therapy in relapsed/refractory CLL
Document type: PBS listing submission summary
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
Utilisation analysis of dasatinib and nilotinib for chronic myeloid leukaemia (CML)
Year: 2024
Region / City: Australia
Theme: Pharmaceutical benefits, Chronic myeloid leukaemia (CML) treatment
Document type: Research analysis
Organization / Institution: Drug Utilisation Sub-Committee (DUSC)
Author: Drug Utilisation Sub-Committee (DUSC)
Target audience: Healthcare professionals, policymakers, pharmaceutical industry
Period of validity: From March 2022 onward
Approval date: October 2024
Date of changes: March 2022
Onureg® Azacitidine Tablets Submission for Maintenance Therapy in Acute Myeloid Leukaemia
Year: 2022
Region / City: Australia
Topic: Oncology / Hematology
Document Type: Submission Report
Organ / Institution: Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Celgene Pty Limited
Target Audience: Healthcare professionals, regulatory authorities
Validity Period: Ongoing
Approval Date: 8 April 2022
Amendment Date: Not specified
PBS Section 85 Authority Required Listing Submission for Venetoclax (Venclexta®) for Relapsed/Refractory Chronic Lymphocytic Leukaemia, 2016–2017
Medicine: Venetoclax
Brand name: Venclexta®
Sponsor: AbbVie Pty Ltd
Dosage forms: Tablets 10 mg, 50 mg, 100 mg
Pack types: Titration pack; Dose hold packs; Maintenance pack
Regulatory authority: Pharmaceutical Benefits Advisory Committee (PBAC)
Regulatory process: TGA/PBAC Parallel Process
ARTG registration date: 5 January 2017
Requested listing: Section 85 Authority Required (PBS)
Indication: Relapsed/refractory chronic lymphocytic leukaemia (CLL)
Patient subgroup: 17p deletion and/or TP53 mutation; highly refractory disease
Comparator: Ofatumumab monotherapy; Rituximab monotherapy
Related assessments: MSAC streamlined co-dependent assessment pathway
Clinical context: Second- and third-line therapy in relapsed/refractory CLL
Document type: PBS listing submission summary
National Institute for Health and Care Excellence Single Technology Appraisal (STA) Gilteritinib for treating relapsed or refractory acute myeloid leukaemia (ID1484) Response to consultee and commentator comments on the draft remit and draft scope (pre-referral) (revised June 2019)
Year: 2019
Region / City: United Kingdom
Topic: Cancer, Hematology
Document Type: Response to Consultation
Organization: National Institute for Health and Care Excellence (NICE)
Author: National Institute for Health and Care Excellence (NICE)
Target Audience: Healthcare professionals, policy makers
Effective Period: Not specified
Approval Date: Not specified
Amendment Date: June 2019
Topics: Venclexta Venetoclax leukaemia