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Durvalumab, sold under the brand name Imfinzi, is an anti-cancer medication used for treatment of various types of cancer. It was developed by Medimmune/AstraZeneca. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to programmed cell death ligand 1 (PD-L1) on cancer cells and blocks interactions with PD-1 and CD80 (B7.1) on T cells.
Read the full article on WikipediaUnresectable Stage III non-small cell lung cancer Clinical criteria: Treatment Phase: Initial treatment Patient must have received platinum based chemoradiation therapy, AND The condition must not have progressed following platinum based chemoradiation therapy, AND Patient must have a WHO performance status of 0 or 1, AND Patient must be untreated with immunotherapy at commencement of this drug, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) Clinical criteria: Population criteria: Patient must have either of the following at treatment initiation: (i) locally advanced biliary tract cancer that is untreated with systemic anti-cancer therapy in the unresectable setting, (ii) metastatic biliary tract cancer that is untreated with systemic anti-cancer therapy in the metastatic setting. Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug. AND The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information), AND Patient must not have developed disease progression while being treated with this drug for this condition.
Extensive-stage small cell lung cancer Clinical criteria: Treatment Phase: Continuing treatment - 4 weekly treatment regimen The treatment must be as monotherapy, AND Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must not have developed disease progression while being treated with this drug for this condition.
Advanced, metastatic or recurrent endometrial carcinoma Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Treatment criteria: Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime. Retain all pathology imaging and investigative test results in the patient's medical records. Patients with a body weight of 30 kg or less during continuing treatment must receive weight-based dosing, equivalent to durvalumab 20 mg/kg, until weight is greater than 30 kg.
Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma Clinical criteria: Treatment Phase: Initial treatment Patient must be undergoing combination treatment with tremelimumab for the first dose of treatment, AND Patient must have a WHO performance status of 0 or 1, AND Patient must not be suitable for transarterial chemoembolisation, AND Patient must have Child Pugh class A, AND The condition must be untreated with systemic therapy; OR Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
Urothelial carcinoma Clinical criteria: Treatment Phase: Initial treatment - neoadjuvant setting Patient must be initiating treatment with this drug for this condition; OR Patient must be transitioning from non-PBS to PBS-subsidised treatment with this drug for this condition, AND The condition must not have previously been treated with systemic therapy for muscle-invasive bladder cancer at the time this drug was initiated for this condition, AND The treatment must be once in a lifetime with this drug for this condition, AND The condition must be of muscle-invasive type disease with both: (i) clinical tumour stage of either T2, T3 or T4a, (ii) nodal status of up to stage N1, AND The treatment must be for neoadjuvant use in a patient preparing for radical cystectomy, AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1, AND The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information). Treatment criteria: Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 4 cycles from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.
Limited-stage small cell lung cancer Clinical criteria: Patient must have received chemoradiation therapy (CRT), AND The condition must not have progressed following CRT, AND Patient must have had a WHO performance status of no greater than 1 at treatment initiation with this drug for this condition, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, AND The treatment must not exceed 24 months in total for this condition, measured from the initial dose, or must not extend beyond disease progression, whichever comes first.
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