Australian Public Assessment Reports (AusPAR)

Tevimbra (tislelizumab) has been approved for the treatment of oesophageal squamous cell carcinoma and non-small cell lung cancer.

Spy Agent Green has been approved as an imaging agent for the fluorescence imaging of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts, lymph nodes and lymphatic vessels.

Yonsa Mpred (abiraterone acetate + methylprednisolone) has been approved for the treatment of metastatic castration resistant prostate cancer and metastatic hormone sensitive prostate cancer.

Koselugo (selumetinib sulfate) has been approved for the treatment of paediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

Cibinqo (Abrocitinib) is approved for the treatment of moderate-to-severe atopic dermatitis in adults.

Tukysa (tucatinib) has been approved to be used in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2 positive unresectable or metastatic colorectal cancer.

Lynparza (olaparib) has been approved for the treatment of BRCA-mutated HER2-negative high risk early breast cancer and metastatic castration-resistant prostate cancer.

Jardiance (empagliflozin) has been approved for reducing the risk of kidney disease progression in adults with chronic kidney disease.

Heparin InterPharma (heparin sodium) has been approved for the prophylaxis and treatment of deep vein thrombosis in patients 18 years and older.

Hemgenix (etranacogene dezaparvovec), a gene therapy, has been approved for the treatment of haemophilia B (congenital factor IX deficiency) in adults.

Ultomiris (ravulizumab) has been approved for the treatment of adult patients with Neuromyelitis Optica Spectrum Disorder who are anti-aquaporin 4 antibody-positive.

Spevigo (spesolimab) has been approved for the treatment of generalised pustular psoriasis, a rare but severe form of psoriasis that involves flares of widespread, non-infectious, macroscopically visible pustules.

Givlaari (givosiran sodium) has been approved for the treatment of acute hepatic porphyria.

Erwinase (crisantaspase) has been approved for the treatment of acute lymphoblastic leukemia (ALL) as a component of a multi-agent chemotherapeutic regimen for patients who have developed hypersensitivity to pegylated asparaginase.

Xeomin (incobotulinumtoxinA) has been approved for the treatment of chronic sialorrhea (hypersalivation or excessive drooling) in children and adults.

Aquipta (atogepant) has been approved for the prophylaxis of migraine in adults who have at least four migraine days per month

Wezlana (ustekinumab) has been approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Raniviz (ranibizumab) has been approved for the treatment of neovascular age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, choroidal neovascularisation and macular oedema.

Nuvaxovid (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 vaccine has been approved for the prevention of coronavirus disease 2019 (COVID-19) caused by SARSCoV-2 in individuals 12 years of age and older.

Adcetris (brentuximab vedotin) has been approved for the treatment of Hodgkin lymphoma in patients with previously untreated CD30+ Stage III or Stage IV Hodgkin lymphoma.

Idefirix (imlifidase) has been approved for the desensitisation treatment of highly sensitised adult kidney transplant candidates prior to kidney transplantation

Onbevzi (bevacizumab) is a biosimilar of Avastin. Onbevzi has been approved to treat a range of cancers either as a monotherapy or in combination with other anti-cancer medicines

Abrysvo is a vaccine that provides active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).

Tecvayli (teclistamab) has been provisionally approved for the treatment of relapsed or refractory multiple myeloma in adult patients.

Arexvy is a vaccine approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older