PBS Adds Zytorvi, First Funded Immunotherapy Option for Australians with Recurrent or Metastatic Nasopharyngeal Carcinoma | iPharmaCenter
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Zytorvi PBS listing
Toripalimab‑based immunotherapy has been added to Australia’s Pharmaceutical Benefits Scheme (PBS) as the first funded immune checkpoint inhibitor for eligible people with nasopharyngeal carcinoma whose disease has recurred or spread.
From 1 December 2025, Zytorvi (toripalimab), a next‑generation PD‑1 inhibitor supplied by Dr. Reddy’s Laboratories under licence from Shanghai Junshi Biosciences, will be reimbursed on the PBS for defined adult nasopharyngeal carcinoma populations. In Australia, the product is approved for use with cisplatin and gemcitabine as initial systemic therapy in metastatic or recurrent, locally advanced disease, and as monotherapy for adults with unresectable recurrent or metastatic nasopharyngeal carcinoma whose cancer has progressed during or after platinum‑containing chemotherapy. Administered as an injection, toripalimab is a monoclonal antibody that targets the PD‑1 pathway, aiming to enhance the immune system’s ability to recognise and attack tumour cells.
The federal subsidy represents a major step forward in access to innovative treatment for a rare head and neck cancer population that has historically depended on radiotherapy, cytotoxic chemotherapy and complex surgery. Many patients with nasopharyngeal carcinoma endure multiple courses of treatment over time, and until now systemic options in the metastatic or relapsed setting have largely been limited to conventional regimens. By reducing out‑of‑pocket costs for toripalimab, the PBS listing is expected to broaden availability of immunotherapy in routine practice and may help address inequities faced by patients with rare cancers.
Nasopharyngeal carcinoma in Australia
Nasopharyngeal carcinoma arises in the nasopharynx, the upper part of the throat behind the nose, and can cause nasal blockage, nosebleeds, changes in hearing, headaches, facial numbness, visual disturbances, difficulty swallowing and respiratory symptoms when advanced.
The disease is associated with Epstein–Barr virus infection, tobacco use and certain dietary patterns such as frequent intake of salted or preserved foods, and has higher incidence in some Asian populations, including people from Southern China and Southeast Asia.
Beyond physical symptoms and visible treatment‑related changes to the face and neck, people with nasopharyngeal and other head and neck cancers often experience considerable psychological distress, including anxiety, depression and concerns about appearance, speech and eating, along with financial strain from ongoing care and potential loss of income.
Nasopharyngeal cancer is an uncommon, aggressive head and neck malignancy that affects around 200 Australians each year, occurring about three times more often in men and typically presenting in people over 40 years of age.
Toripalimab - Mechanism of action
Toripalimab for nasopharyngeal carcinoma is supplied as an injectable formulation containing the active monoclonal antibody, which binds to PD‑1 on T cells to block inhibitory signalling and promote anti‑tumour immune activity.
Access to this medicine under the PBS is intended for specific adult patient groups defined in the Australian product information and PBS criteria, and decisions on its use should be made by treating specialists as part of multidisciplinary cancer care. For many patients, optimal management of nasopharyngeal carcinoma requires coordinated support from oncology, radiation, surgical, nursing, allied health and psychosocial teams, alongside family and community resources, to address the combined clinical, emotional and practical impacts of the disease.