Australian Public Assessment Reports (AusPAR)

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.

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

Comirnaty Original/Omicron BA.4-5 (tozinameran/famtozinameran) is provisionally approved to prevent COVID-19 in individuals 5 years of age and older.

Andexxa (andexanet alfa) is provisionally approved for adult patients treated with a direct factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Gavreto (pralsetinib) has been approved for the treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer.

AusPAR for Camzyos (mavacamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy.

AusPAR for Pemazyre (pemigatinib) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy.

AusPAR for Opdivo (nivolumab) for the treatment of adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC).

AusPAR for Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome

AusPAR for Filpegla (pegfilgrastim) for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia.

AusPAR for Prevenar 20 (pneumococcal polysaccharide conjugate vaccine) for the prevention of pneumococcal disease caused by Streptococcus pneumoniae.

AusPAR for Keytruda (pembrolizumab) for the treatment of triple-negative breast cancer.

AusPAR for JAKAVI (ruxolitinib phosphate) for the treatment of graft-versus-host disease.

New AusPAR for Spikevax (elasomeran) for the prevention of COVID-19 caused by SARS-CoV-2.

BIMZELX (bimekizumab) for treatment of moderate to severe plaque psoriasis in adult patients .

AusPAR for DUPIXENT dupilumab for the treatment of asthma.

AusPAR for RINVOQ (Upadacitinib) for treatment of atopic dermatitis in patients aged 12 years and above.

AusPAR for Eligard (Leuprorelin acetate) for the treatment of children with central precocious puberty (CPP).

AusPAR for Padcev (Enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed receptor-1 or programmed death-ligand-1 inhibitor.

AusPAR for Maviret (glecaprevir /pibrentasvir) for the treatment of adult and paediatric patients with chronic hepatitis C virus.

AusPAR for Bijuva 1/100 (estradiol hemihydrate and progesterone) for use during HRT for estrogen deficiency symptoms.