RETIFANLIMAB

The PBAC recommended the listing of retifanlimab when used together with chemotherapy (carboplatin and paclitaxel), to treat people with cancer of the lining of the anus, specifically those with squamous cell anal cancer (SCAC) that cannot be removed by surgery, has spread, and has not been previously treated with chemotherapy. 
The PBAC recalled input from health professionals and organisations in relation to the November 2025 submission, noting the severity of disease and need for new treatments for this rare cancer. The PBAC recalled it previously accepted that retifanlimab was more effective than chemotherapy alone at delaying cancer progression.
The PBAC recalled it had previously deferred making a decision on the PBS listing of retifanlimab as it was unknown at the time if the Therapeutic Goods Administration (TGA) would approve its registration. After receiving confirmation that the TGA was likely to approve retifanlimab, the PBAC recommended that retifanlimab be listed at a lower price commensurate with the benefit it provides over chemotherapy. The PBAC considered that the lower price should be determined based on the economic model with updated inputs provided by the sponsor prior to the PBAC meeting.