Australian Public Assessment Reports (AusPAR)

AusPAR for Nuceiva (prabotulinum toxin A) for temporary improvement in appearance of glabellar lines.

AusPAR for WELIREG (belzutifan) is indicated for treatment of patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery.

AusPAR for Vazkepa (icosapent ethyl) to reduce the risk of cardiovascular events.

AusPAR for Comirnaty (tozinameran) for the prevention of coronavirus disease 2019 (COVID-19)

Withdrawn submission related to AusPAR for MVC COVID-19 Vaccine, for the prevention of novel coronavirus disease (COVID-19).

AusPAR for Vaxneuvance (Pneumococcal 15-valent conjugate vaccine (CRM197 protein), adsorbed) for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes.

AusPAR for Spikevax Bivalent Original/Omicron BA.4 - 5 (Elasomeran/davesomeran) for the prevention of coronavirus disease 2019 caused by SARS-CoV-2.

AusPAR for Gardasil 9 (HPV 9-valent vaccine, recombinant) for prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by HPV in males.

Keytruda (pembrolizumab) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

AusPAR for Rybrevant (amivantamab) for treatment of patients with NSCLC that has an EGFR exon 20 insertion mutation.

AusPAR for Sotyktu (deucravacitinib) for treatment of adult patients with moderate-to-severe plaque psoriasis.

AusPAR for Onpattro (patisiran) for treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

AusPAR for Trecondi for the treatment of adults with acute myeloid leukaemia or myelodysplastic syndrome, and paediatric population with malignant and non-malignant haematological diseases.

AusPAR for full registration for COMIRNATY (tozinameran) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

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 Keytruda (pembrolizumab) for the treatment of Oesophageal Cancer

AusPAR for withdrawn Aduhelm (aducanumab) for proposed treatment of Alzheimer’s disease.

AusPAR for Keytruda (pembrolizumab) for the treatment relapsed or refractory classical Hodgkin Lymphoma

AusPAR for Keytruda (pembrolizumab) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

AusPAR for Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.

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

AusPAR for Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies

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

AusPAR for Lucentis (ranibizumab) for the treatment of retinopathy of prematurity