№ files_lp_4_process_3_127253
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Regulatory submission and clinical evaluation source detailing efficacy, safety, and economic considerations for extending PBS listing of ribociclib combined with fulvestrant in advanced or metastatic breast cancer.
Year: 2020
Regulatory body: Pharmaceutical Benefits Advisory Committee (PBAC)
Region: Australia
Drug: Ribociclib (Kisqali)
Combination therapy: Fulvestrant
Indication: Hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer
Population: Non-premenopausal adults
Clinical trials referenced: MONALEESA-2, MONALEESA-3, BOLERO-2
Treatment line: First-line and second-line therapy
Outcome measures: Progression-free survival, overall survival, overall response rate, adverse events, health-related quality of life
Economic analysis: Cost-minimisation (first-line), cost-effectiveness (second-line)
Submission type: Major submission with minor resubmission for economic model adjustment
Approval status: TGA-approved ribociclib (2017, updated 2020), fulvestrant generic approved 2020
Manufacturer: Novartis Pharmaceuticals Australia Pty Ltd / Sandoz
Date of PBAC meeting: July 2020
Price: 8 / 10 USD
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ESR1 F404 mutations and fulvestrant resistance in ESR1 mutant breast cancer
Year: 2026
Region / City: London, United Kingdom; Urbana, Illinois, USA; New York City, USA; Glasgow, United Kingdom
Topic: Breast cancer, ESR1 mutations, drug resistance
Document Type: Research article
Institution: The Institute of Cancer Research; University of Illinois at Urbana-Champaign; Memorial Sloan Kettering Cancer Center; Weill Cornell Medical College; The Royal Marsden Hospital
Authors: Belinda Kingston, Alex Pearson, Maria Teresa Herrera-Abreu, Li-Xuan Sim, Rosalind J Cutts, Heena Shah, Laura Moretti, Lucy S Kilburn, Hannah Johnson, Iain R Macpherson, Alistair Ring, Judith M Bliss, Yingwei Hou, Weiyi Toy, John A Katzenellenbogen, Sarat Chandarlapaty, Nicholas C Turner
Keywords: Fulvestrant, acquired resistance, ESR1 F404, breast cancer, PIK3CA, TP53, ESR1 D538G, ESR1 E380Q, ESR1 Y537N
Methods: Patient cohort analysis, progression-free survival assessment, CRISPR gene editing, RNA sequencing, clonogenic assays
Target Audience: Oncologists, cancer researchers, molecular biologists
Supplementary Data: Figures 1–9, mutation incidence, gene expression, drug response curves
Clinical Focus: Acquired resistance to fulvestrant in ESR1 mutant breast cancer models
RIBOCICLIB Tablet 200 mg, Kisqali®, NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED
Year: 2025
Region / City: Australia
Topic: Pharmaceutical submission
Document Type: Pharmaceutical submission
Organization / Institution: Novartis Pharmaceuticals Australia Pty Limited
Author: Not specified
Target Audience: Medical practitioners
Period of validity: Until March 2025
Approval Date: November 2024
Modification Date: Not specified
Topics: HR+HER2- fulvestrant Ribociclib