IMFINZI (durvalumab) Now Available for Eligible Patients
Access pathways now open in Australia and New Zealand for the NIAGARA regimen for muscle invasive bladder cancer (MIBC): Neoadjuvant IMFINZI + gem-cis followed by adjuvant IMFINZI monotherapy after radical cystectomy.1,2
Australia – PBS Listing
IMFINZI is now listed on the Pharmaceutical Benefits Scheme (PBS) for eligible patients with muscle invasive bladder cancer.3
Indication: IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with muscle invasive bladder cancer (MIBC).1
PBS Item Code: Public: 15292W. Private: 15283J.3
View the full eligibility criteria in the neoadjuvant and adjuvant setting.
View more IMFINZI information, including efficacy, safety, dosing and patient material.
PBS Information: Authority required (STREAMLINED): Refer to PBS Scheule for full information.
Please click here to review full product information before prescribing. Further information available on request from AstraZeneca.
References: 1. IMFINZI® (durvalumab) Approved Product Information. 2. Powles T et al. N J Med 2024;391(19):1773-1786 (including Supplementary Appendix). 3. Pharmaceutical Benefits Scheme www.pbs.gov.au Accessed April 2026.
IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via the website. AU-25293. May 2026.
New Zealand – Co-Pay Patient Access Program
A Co-Pay Patient Access Program (PAP) is now open for eligible patients with muscle invasive bladder cancer in New Zealand.
Indication: IMFINZI in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
Eligible patients:
- Confirmed MIBC (T2–T4a, N0/1) planned for radical cystectomy
- IMFINZI treatment initiated with both gemcitabine and cisplatin in the neoadjuvant phase
- Aged ≥18 years
- Eligible for NZ publicly funded healthcare
To enrol patients or download the PAP HCP Guide: visit the Access AZ website or download the PAP HCP Guide.
Before prescribing, please review full Medsafe approved data sheet, available on request from AstraZeneca on +64 (9) 306 5650 OR 0800 684 432 or at http://www.medsafe.govt.nz/.
IMFINZI® 50mg/mL, concentrated solution for infusion. IMFINZI (durvalumab) 120mg/2.4mL or 500mg/10mL, concentrated solution for infusion in a single-dose vial. Prescription Medicine. Therapeutic Indications: Urothelial carcinoma: in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). Dosage and Administration: IMFINZI is administered as an intravenous (IV) infusion over 1 hour. MIBC: 1500mg in combination with chemotherapy every 3 weeks for 4 cycles prior to surgery, followed by 1500 mg every 4 weeks as monotherapy for up to 8 cycles after surgery, until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 8 cycles after surgery. Patients with a body weight of 30 kg or less must receive weight- based dosing of IMFINZI at 20 mg/kg. In combination with chemotherapy, dose IMFINZI at 20 mg/kg every 3 weeks prior to surgery, followed by monotherapy at 20 mg/kg every 4 weeks after surgery until weight increases to greater than 30 kg. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Immune-mediated adverse reactions (imARs): Immune checkpoint inhibitors, including IMFINZI, can cause severe and fatal imARs, which may involve any organ system. Patients should be monitored for signs and symptoms associated with imARs including: immune-mediated pneumonitis and radiation pneumonitis, hepatitis, colitis, immune-mediated endocrinopathies including hypothyroidism/hyperthyroidism/thyroiditis, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis/hypopituitarism, nephritis, dermatological adverse reactions, myocarditis (which can be fatal); and other imARs, e.g. aseptic meningitis, haemolytic anaemia, immune thrombocytopenia, myasthenia gravis, myelitis transverse, myositis, polymyositis, rhabdomyolysis, Guillain-Barré syndrome, pancreatitis, immune- mediated arthritis, encephalitis and ocular inflammatory toxicity, including uveitis and keratitis. See Data Sheet for further information on monitoring and management recommendations for imARs. Infusion related reactions: Monitor patients for signs and symptoms, severe reactions have been reported. Efficacy in patients with PD-L1 expression <1%: efficacy may be different, see full Data Sheet. Paediatric use: safety and efficacy not established in patients less than 18 years. Use in pregnancy: Category D. Durvalumab has the potential to impact maintenance of pregnancy and may cause foetal harm. Not recommended during pregnancy; women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose. Breast-feeding: lactating women should be advised not to breastfeed during treatment and for at least 3 months after the last dose. Adverse Reactions: The safety of IMFINZI as monotherapy is based on pooled data in 3006 patients from 9 studies across multiple tumour types. The safety of IMFINZI in combination with chemotherapy is based on data in 265 patients from the CASPIAN (SCLC) study,338 patients from the TOPAZ-1 (BTC) study and 530 patients from the NIAGARA (MIBC) study and was consistent with IMFINZI monotherapy and known chemotherapy safety profiles. The safety of IMFINZI in combination with chemotherapy as neoadjuvant treatment, is based on data in 401 patients from the AEGEAN (resectable NSCLC) study and was consistent with known IMFINZI monotherapy and known chemotherapy safety profiles. The safety of IMFINZI in combination with platinum-based chemotherapy followed by IMFINZI as monotherapy (N=235) or in combination with olaparib (N=238) is based on data in patients from the DUO-E (endometrial cancer) study. The safety profile was consistent with IMFINZI monotherapy and known olaparib and chemotherapy safety profiles, with PRCA identified as associated specifically when olaparib is added to IMFINZI in the maintenance phase. Very Common (≥ 10%): Cough/productive cough, abdominal pain, diarrhoea, hypothyroidism, rash, pruritus, pyrexia, upper respiratory tract infections. Common (≥ 1%): Pneumonitis, dysphonia, increased aspartate aminotransferase or alanine aminotransferase, hyperthyroidism, increased blood creatinine, dysuria, night sweats, peripheral oedema, pneumonia, oral candidiasis, dental and oral soft tissue infections, influenza, myalgia, infusion related reaction. See Data Sheet for other listed adverse reactions including immune-mediated adverse reactions.
IMFINZI is not funded for urothelial carcinoma. A prescription charge will apply. Please refer to the Pharmaceutical Schedule. Before prescribing IMFINZI, please read the manufacturer’s Data Sheet available at the Medsafe website.
IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Limited, PO Box 87453, Meadowbank, Auckland 1742. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 0800 684 432 or (09) 306 5650 or via the AstraZeneca website. May 2026, AU-25293, TAPS MR13428.