Australian Public Assessment Reports (AusPAR)

Sephience (sepiapterin) has been approved for the treatment of hyperphenylalaninaemia in adult and paediatric patients with phenylketonuria.

Nexobrid (anacaulase-bcdb) has been approved for eschar removal in adults and paediatric patients with deep partial thickness and/or full thickness thermal burns.

Enrylaze (crisantaspase) has been approved as a component of a multi-agent chemotherapeutic regimen, for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.

Afqlir; Enzeevu (aflibercept) 2 mg is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (wet AMD), CRVO, BRVO, DMEmyopic and CNV.

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is approved for treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Eydenzelt (aflibercept) has been approved for the treatment in adults of visual impairment due to myopic choroidal neovascularisation.

Plaque psoriasis Uteknix is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Lamzede (velmanase alfa) has been approved as an enzyme replacement therapy for the treatment of non-central nervous system manifestations in patients with alpha-mannosidosis.

Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.

Dexrazoxane-Reach is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumour control.

Nemluvio (nemolizumab) has been approved to treat moderate-to-severe atopic dermatitisin combination with topical corticosteroids and/ or topical calcineurin inhibitors in adults and patients aged 12 years and above who weigh at least 30 kg and who are candidates for systemic therapy. Nemluvio has also been approved for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Lazcluze (lazertinib) in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

Vyloy (zolbetuximab), in combination with fluoropyrimidine and platinum-containing chemotherapy, has been approved for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GOJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.

Leqembi is indicated in adult patients with a diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) that are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes. Beta amyloid evidence consistent with Alzheimer’s disease (AD) should be confirmed using a validated test prior to initiating treatment.

Tepezza has been approved for the treatment of moderate to severe Thyroid Eye Disease.

Capvaxive is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older.

Skytrofa (lonapegsomatropin) is for the treatment of growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion.

Elucirem/Vueway (gadopiclenol) is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualise lesions with abnormal blood brain barrier or abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system).

Winrevair (sotatercept) has been approved for the treatment of adults with pulmonary arterial hypertension (PAH) in WHO Functional Class (FC) II or III, in combination with standard therapy.

Fruzaqla (fruquintinib) is approved for the treatment of adult patients with metastatic colorectal cancer (mCRC).

AVTOZMA (tocilizumab), a biosimilar to ACTEMRA, has been approved to treat multiple autoimmune and inflammatory conditions.

DATROWAY (datopotamab deruxtecan) as a monotherapy is for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one additional systemic therapy in the locally advanced or metastatic setting.

IQIRVO (elafibranor) is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

OMLYCLO (omalizumab), a biosimilar to XOLAIR, is approved to treat allergic asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.

Pyrazinamide-AFT is indicated in adult patients of more than 12 years of age with active drug-sensitive tuberculosis caused by Mycobacterium tuberculosis. Pyrazinamide-AFT is an anti-tuberculosis agent used in combination with other anti- tuberculosis agents and is commonly used in the first 2 months of treatment.