Australian Public Assessment Reports (AusPAR)

Vafseo (vadadustat) has been approved for the treatment of anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Elrexfio has provisional approval for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and have demonstrated disease progression on the last therapy.

Brukinsa (zanubritinib) was approved to treat adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma, including patients with deletion 17p and/or TP53 mutation.

Kalydeco (ivacaftor) was approved to treat cystic fibrosis in patients aged 4 months and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.

Paxlovid has been approved for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death.

Vaxchora (vibrio cholerae) vaccine has been approved for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older travelling to cholera-affected countries.

Vyalev (foslevodopa and foscarbidopa) has been approved to treat idiopathic Parkinson’s disease with severe motor fluctuations despite optimised alternative pharmacological treatment.

Jubbonti, a biosimilar to Prolia, and Wyost, a biosimilar to Xgeva (both denosumab), have been approved to improve bone density and to reduce bone fracture risk as a consequence of disease or medications that weaken bones.

Ebglyss (lebrikizumab) has been approved to treat severe atopic dermatitis in adult and adolescent patients.

Nubeqa has been approved to treat metastatic hormone-sensitive prostate cancer in combination with docetaxel.

Mounjaro (tirzepatide) has been approved, as an adjunct to a reduced-calorie diet and increased physical activity, for chronic weight management.

Kyprolis (carfilzomib) has been approved to treat relapsed or refractory multiple myeloma.

COMIRNATY Original/Omicron BA.4-5 Vaccine has been provisionally approved for immunisation against coronavirus disease 2019 (COVID-19) caused by SARSCoV-2 in individuals 6 months of age or older.

Amvuttra (vutrisiran) has been approved for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with polyneuropathy.

Velsipity (Etrasimod) has been approved for the treatment of adults with moderately to severely active ulcerative colitis who have not benefited from prior therapies

Opdivo (nivolumab), in combination with platinum-doublet chemotherapy, has been approved for the neoadjuvant treatment of patients with resectable non-small cell lung cancer.

Lokelma (sodium zirconium cyclosilicate hydrate) has been approved for the treatment of hyperkalaemia in adult patients.

Polivy (Polatuzumab vedotin) has been approved for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma.

Enhertu (trastuzumab deruxtecan) has been approved to treat adult patients with unresectable or metastatic HER2-low breast cancer.

Onakta (tirbanibulin) was approved for the topical field treatment of actinic keratosis of the face or scalp in adults.

Wegovy has been approved for weight management in obese adolescents ages 12 years and above (as an adjunct to a reduced-calorie diet and increased physical activity).

Wegovy (semaglutide)has been approved as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults.

Xeljanz (tofacitinib) has been approved for the treatment of ankylosing spondylitis and for active polyarticular course juvenile idiopathic arthritis.

Rinvoq (upadacitinib) has been approved for the treatment of adults with active non-radiographic axial spondyloarthritis.

Nelarabine-Reach has been approved to treat patients with relapsing /refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.