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Pembrolizumab, sold under the brand name Keytruda, is a humanized monoclonal antibody, more specifically a PD-1 inhibitor, used in cancer immunotherapy to treat many types of cancer. It is administered by slow intravenous injection.
Read the full article on WikipediaUnresectable Stage III or Stage IV malignant melanoma Clinical criteria: Treatment Phase: Continuing treatment - 3 weekly treatment regimen The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must have previously been issued with an authority prescription for this drug for this condition, AND Patient must have stable or responding disease.
Relapsed or Refractory Hodgkin lymphoma Clinical criteria: Treatment Phase: Initial treatment Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition, AND Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition, AND The treatment must be the sole PBS-subsidised therapy for this condition. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
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.
Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Clinical criteria: Treatment Phase: Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition, AND The condition must have progressed on or after prior platinum based chemotherapy; OR The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer, AND Patient must have a WHO performance status of 2 or less, 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. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Clinical criteria: Treatment Phase: Initial treatment - 3 weekly treatment regimen The treatment must be in addition to complete surgical resection, AND Patient must have a WHO performance status of 1 or less, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must not have received prior PBS-subsidised treatment for this condition, AND The treatment must commence within 12 weeks of complete resection, AND Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).
Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Clinical criteria: Treatment Phase: Continuing treatment - 3 weekly treatment regimen Treatment criteria: Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing. Patient must not have experienced disease recurrence, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).
Relapsed or refractory primary mediastinal B-cell lymphoma Clinical criteria: Treatment Phase: Initial treatment The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, AND Patient must have been treated with rituximab-based chemotherapy for this condition, AND Patient must be experiencing relapsed/refractory disease, AND Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR Patient must have undergone an autologous stem cell transplant (ASCT); OR Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy, 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 the sole PBS-subsidised therapy for this condition. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Clinical criteria: Treatment Phase: Initial treatment Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease), AND Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor, AND Patient must have a WHO performance status of 0 or 1, AND Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Clinical criteria: Treatment Phase: Initial treatment The condition must be incurable by local therapies in the locally advanced setting, AND Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition, AND Patient must not have previously received programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy for any earlier stage of squamous cell carcinoma of the oral cavity, pharynx or larynx, AND Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting, AND Patient must have had a WHO performance status of 0 or 1, AND The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Stage IV clear cell variant renal cell carcinoma (RCC) Clinical criteria: Treatment Phase: Initial treatment Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records, AND The condition must be untreated, 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 Patient must have a WHO performance status of 2 or less. Treatment criteria: Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records, AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Advanced, metastatic or recurrent endometrial carcinoma Clinical criteria: Treatment Phase: Initial treatment Patient must have received prior treatment with platinum-based chemotherapy, AND The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy, AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation. Treatment criteria: Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records, AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Recurrent, unresectable or metastatic triple negative breast cancer Clinical criteria: The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage, AND The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer, AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation, AND The treatment must be in combination with chemotherapy, AND The condition must have both: (i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation. Treatment criteria: Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; OR Patient must be undergoing continuing treatment with this drug - both the following are true: (i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose, AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Advanced carcinoma of the cervix Clinical criteria: Treatment Phase: Initial treatment The condition must be at least one of (i) persistent carcinoma, (ii) recurrent carcinoma, (iii) metastatic carcinoma of the cervix, AND The condition must be unsuitable for curative treatment with either of (i) surgical resection, (ii) radiation, AND Patient must have WHO performance status no higher than 1, AND Patient must not have received prior PBS-subsidised treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor in any earlier line of carcinoma of the cervix. Treatment criteria: Patient must be undergoing concomitant treatment with chemotherapy, containing a minimum of: (i) a platinum-based chemotherapy agent, plus (ii) paclitaxel, AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Stage II or Stage III triple negative breast cancer Clinical criteria: The treatment must be initiated in combination with neoadjuvant chemotherapy, AND The condition must not have progressed/recurred whilst on treatment with this drug. Treatment criteria: Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction, AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 4 repeat prescriptions.
Intermediate or high risk of recurrence clear cell variant renal cell carcinoma (RCC) Clinical criteria: Patient must have: (i) pT2 with Grade 4 or sarcomatoid features; or (ii) pT3, with any grade without nodal involvement (N0) or distant metastases (M0); or (iii) pT4, any grade N0 and M0; or (iv) any pT, any grade with nodal involvement and M0; or (v) metastatic disease and has undergone complete resection of primary and metastatic lesions, AND The treatment must be in addition to complete surgical resection, AND The treatment must commence within 12 weeks of complete resection, AND Patient must have a WHO performance status of 1 or less, AND Patient must not have previously been treated with systemic therapy for this condition, prior to commencing treatment with this drug for this condition, AND The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition, AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
High risk locally advanced carcinoma of the cervix Clinical criteria: Treatment Phase: Initial treatment Patient must have high-risk, locally advanced cervical cancer of one of the following types: (i) squamous cell carcinoma, (ii) adenosquamous carcinoma, (iii) adenocarcinoma, AND The treatment must be/have been commenced in combination with concurrent chemoradiotherapy, AND Patient must have a WHO performance status of 1 or less, AND Patient must not have received prior PBS-subsidised treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for carcinoma of the cervix, AND The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
Resectable locally advanced squamous cell carcinoma of the oral cavity, pharynx or larynx Clinical criteria: Patient must have stage III-IVB squamous cell carcinoma of the oral cavity, pharynx or larynx, AND Patient must have tumour(s) that are resectable as assessed by the treating clinician; OR Patient must have undergone surgical resection, AND Patient must have a WHO performance status of 1 or less, AND Patient must not have experienced disease recurrence or progression while being treated with this drug for this condition, AND The treatment must be commenced as neoadjuvant therapy and continued in combination with radiation therapy with or without chemotherapy after surgical resection; OR The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, AND The treatment must not exceed a total of 12 cumulative months, either as: (i) 17 doses (based on a 3-weekly dose regimen), (ii) 8 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless of if it was PBS/non-PBS subsidised. Treatment criteria: Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
“Pembrolizumab is a therapeutic antibody that binds to and blocks PD-1 located on lymphocytes. This receptor is generally responsible for preventing the immune system from attacking the body's own tissues; it is a so-called immune checkpoint. Normally, the PD-1 receptor on activated T-cells binds to the PD-L1 or PD-L2 ligands present on normal cells in the body, deactivating any potential cell-mediated immune response against these cells. Many cancers make proteins such as PD-L1 that also bind to the PD-1 receptor, thus shutting down the ability of the body to kill the cancer. Pembrolizumab works by inhibiting lymphocytes' PD-1 receptors, blocking the ligands that would deactivate it and prevent an immune response.[medical citation needed] This allows the immune system to target and destroy cancer cells, but also blocks a key mechanism preventing the immune system from attacking the body itself. This checkpoint inhibitor function of pembrolizumab thus has immune-dysfunction side effects as a result.”
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