PBAC's latest decision on Retifanlimab: Recommended with restriction (2025). Considered for Treatment of inoperable locally recurrent or metastatic squamous cell anal carcinoma (SCAC) not previously treated with systemic chemotherapy, used in combination with carboplatin and paclitaxel as first-line therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Adults with inoperable locally recurrent or metastatic squamous cell anal carcinoma not previously treated with systemic chemotherapy, eligible for first-line combination therapy with carboplatin and paclitaxel.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
308 patients
Key trials
POD1UM-303
Comparator
carboplatin and paclitaxel (CP)
Economic model
CUA
ICER note
ICER values are redacted (denoted as '&&&&' in the pricing table); economic model details not disclosed in this public summary document.
Submission history
Nov 2025: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required