Section A: Pre-market registration applications referred for advice
At this meeting, the committee’s advice was sought on 11 applications under evaluation by the TGA. The applications included:
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area |
|---|---|---|
| Type A (new biological entity) | ||
| faricimab (VABYSMO) | Roche Products Pty Ltd | For treatment of neovascular age-related macular degeneration and diabetic macular oedema. |
| Type A (new chemical entity) | ||
| asciminib (as hydrochloride) (SCEMBLIX) | Novartis Pharmaceuticals Australia Pty Ltd | For treatment of Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase. |
| Type C (extension of indications) | ||
| cabotegravir (APRETUDE) | ViiV Healthcare Pty Ltd | |
| leuprorelin acetate (ELIGARD) | Mundipharma Pty Ltd | |
| nivolumab (OPDIVO) | Bristol Myers Squibb Australia Pty Ltd | For adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC). |
| pembrolizumab (KEYTRUDA) | Merck sharp and Dohme (Australia) Pty Ltd | For treatment of renal cell carcinoma. |
| < pembrolizumab (KEYTRUDA) | Merck sharp and Dohme (Australia) Pty Ltd | For treatment of triple-negative breast cancer (TNBC) |
| ravulizumab (ULTOMIRIS) | Alexion Pharmaceuticals Australia Pty Ltd | For treatment of atypical haemolytic uraemic syndrome. |
*These application types are published on Prescription medicines: applications under evaluation.
In addition to:
- Two seeking a major variation (change in dosage)
- One seeking input on a long-term application for consent to import, supply or export goods that do not conform with standards
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). Please note that there is a delay from when an application was considered at ACM and the publication of the AusPAR. Browse all AusPARs.
Further information
For further information visit the Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.