Australian Public Assessment Reports (AusPAR)

Eladynos (abaloparatide) has been approved for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Based on a review of quality, safety, and efficacy data, the TGA decided not to register Leqembi (lecanemab) for the proposed indication.

Columvi (glofitamab), with obinutuzumab pretreatment, was provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi is not indicated for the treatment of patients with primary central nervous system lymphoma.

Truqap (capivasertib), in combination with fulvestrant, was approved for the treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.

Gazyva (obinutuzumab) was approved as a pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab.

Verdye (indocyanine green) is a non-toxic medical dye that is injected intravenously and is used to measure certain cardiac, circulatory and liver functions. This medicinal product is for diagnostic use only.

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

Elrexfio (elranatamab) was provisionally approved 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 (nirmatrelvir and ritonavir) was 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) was 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) was 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), were approved to improve bone density and to reduce bone fracture risk as a consequence of disease or medications that weaken bones.

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

Nubeqa (darolutamide) was approved to treat metastatic hormone-sensitive prostate cancer in combination with docetaxel.

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

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

Comirnaty Original/Omicron BA.4-5 Vaccine was 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) was 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, was approved for the neoadjuvant treatment of patients with resectable non-small cell lung cancer.

Lokelma (sodium zirconium cyclosilicate hydrate) was approved for the treatment of hyperkalaemia (high potassium levels in blood) in adult patients.

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

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