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Recurrent or metastatic nasopharyngeal carcinoma Clinical criteria: Patient must have a WHO performance status of no higher than 2, AND The condition must not be amenable to salvage surgery or radiotherapy, AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition, AND The treatment must be commenced in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting (i.e. used in combination with PBC for 6 cycles in the first line setting unless intolerance/contraindication is confirmed); OR The treatment must be the sole PBS-subsidised therapy at the time of treatment initiation where the condition has progressed following treatment with PBC (i.e. used as monotherapy in the second line setting). Treatment criteria: Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 cumulative months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. An increase above the listed maximum amount may only be requested when a dose of 3 mg/kg every 2 weeks is prescribed in the second line setting.
“Toripalimab is a humanised IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway mediated inhibition of the immune response, including the anti-tumour immune response.”
“The mean terminal half-life (t ½ ) (± standard deviation) was 10 ± 1.5 days after the first dose and 18 ± 9.4 days at steady state.”
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Monoclonal antibodies such as toripalimab are not substrates for cytochrome P450 or drug transporters.”