ToripalimabZytorvi
First-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine, or second-line treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
Decision on record
- Meeting Mar 2025 Recommended Nasopharyngeal carcinoma, recurrent or metastatic
Access path
- TGA registered · Zytorvi
TGA label narrower than the PBS population
- Jul 2025Recommended · restricted
vs Cisplatin-gemcitabine (first-line); single-agent…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (STREAMLINED) listing of toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy Program (EFC)). The PBAC considered it reasonable for toripalimab to be available for patients in the first- and second-line setting.PSD · Mar 2025
OFFICIAL Public Summary Document – March 2025 PBAC Meeting with July 2025 Addendum demonstrated a progression-free and overall survival (OS) benefit for toripalimab given in combination with cisplatin and gemcitabine (Cis+Gem) over the comparator (Cis+Gem alone) but that the magnitude of benefit in the Australian population likely to be treated was uncertain.PSD · Mar 2025
6.26 The submission presented a cost-utility analysis comparing toripalimab in combination with Cis+Gem followed by toripalimab maintenance therapy and placebo in combination with Cis+Gem followed by placebo maintenance therapy for 1L treatment of RM-NPC. This was consistent with a claim of superior effectiveness.PSD · Mar 2025
6.27 The submission did not present an economic evaluation for second-line use of toripalimab. The PSCR stated that second-line use is likely to be low and that there was precedent for a line-agnostic listing (para 7.15, selpercatinib Public Summary Document (PSD), July 2024 PBAC meeting), particularly since the 2025 version of the National Comprehensive Cancer Network Guidelines for head and neck cancer lists toripalimab used in combination with …PSD · Mar 2025
In patients with RM-NPC who have previously progressed while on chemotherapy, toripalimab provides a clinically meaningful treatment response and duration of response, while demonstrating a manageable safety profile. Source: Table 1-1, pp 25 of the submission.PSD · Mar 2025
NPC, nasopharyngeal carcinoma; SoC, standard of care 1 OFFICIALPSD · Mar 2025
Rare Cancers Australia highlighted that patients with NPC have a poor prognosis, that there is significant morbidity associated with the condition and that patients face significant financial burden. The Medical Oncology Group of Australia (MOGA) expressed its strong support for the toripalimab submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the JUPITER-02 and POLARIS-02 trial.PSD · Mar 2025
Cost-effectiveness
ICER not stated or published in the public summary document.
Decision context
PopulationAdults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma with ECOG performance status 0 or 1 (not amenable to salvage surgery or re-irradiation in the first-line setting), with no prior systemic therapy for the first-line indication, or with disease progression on prior platinum-containing chemotherapy for the second-line indication.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | Cisplatin-gemcitabine (first-line); single-agent chemotherapy (second-line) | — | RCT · PFS |
Consumer voice
Rare Cancers Australia highlighted poor prognosis and significant morbidity and financial burden for NPC patients. The Medical Oncology Group of Australia expressed strong support for toripalimab PBS listing based on clinical trial evidence, though noting limited ESMO-MCBS scores.
Rare Cancers Australia highlighted that patients with NPC have a poor prognosis, that there is significant morbidity associated with the condition and that patients face significant financial burden. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ECOG 0-1 performance status and excludes patients amenable to salvage surgery or re-irradiation in first-line setting.