PBAC's latest decision on Zolbetuximab: Recommended with restriction (2025). Considered for First-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumours are CLDN18.2-positive.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumours (≥75% of tumour cells demonstrating moderate to strong membranous CLDN18 IHC staining) with WHO performance status no higher than 1, untreated with PD-1/PD-L1 inhibitor therapy for gastro-oesophageal cancer.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
GLOW, SPOTLIGHT, FAST
Comparator
nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis (CMA) submitted; no ICER calculated.