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Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Clinical criteria: Treatment Phase: Initial treatment covering the first 3 treatment cycles The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy, AND Patient must have had a WHO performance status of 0 or 1, AND The treatment must be the sole PBS-subsidised therapy for this condition.
Stage IV (metastatic) non-small cell lung cancer (NSCLC) Clinical criteria: Treatment Phase: Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition, 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 non-small cell lung cancer, AND Patient must have a WHO performance status of 0 or 1, AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material, AND The treatment must not exceed a total of 7 doses under this restriction.
“Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2.”
“The within dosing interval half-life at steady state is 22 days.”
Working under the parallel aged-care framework? Aged-care equivalent →
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.