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.

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.

New AusPAR for VUMERITY (diroximel fumarate) to reduce relapses and delay progression of disability in multiple sclerosis patients.

New AusPAR for Jemperli (dostarlimab) for the treatment of mismatch repair deficient endometrial cancer.

New AusPAR for Vyxeos (daunorubicin and cytarabine) for the treatment of acute myeloid leukaemia.

New AusPAR for Vaxelis (DTPa5-Hep B-IPV-Hib) for primary and booster vaccination.