PBAC's latest decision on Repotrectinib: Recommended with restriction (2025). Considered for Treatment of adult patients with locally advanced (Stage IIIB) or metastatic (Stage IV) c-ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC).
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
Adult patients with locally advanced (Stage IIIB) or metastatic (Stage IV) ROS1-positive non-squamous NSCLC, with WHO performance status ≤2, with evidence of ROS1 gene rearrangement, either TKI-naïve or intolerant to prior ROS1 receptor tyrosine kinase inhibitors.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
Single-arm
Primary endpoint
ORR
Pivotal trial size
63 patients
Key trials
TRIDENT-1
Comparator
entrectinib
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated by design.