Section A: Premarket registration applications
At this meeting, the committee provided advice on 6 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A) | |||
| lenacapavir (SUNLENCA) | Gilead Sciences Pty Ltd | For treatment of human immunodeficiency virus type 1 (HIV-1) | |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
| carfilzomib (KYPROLIS) | Amgen Australia Pty Ltd | For the treatment of relapsed or refractory multiple myeloma in combination with daratumumab and dexamethasone | |
| ibrutinib (IMBRUVICA) | Janssen-Cilag Pty Ltd | For treatment of leukaemia and lymphoma | |
| zanubrutinib (BRUKINSA) | BeiGene AUS Pty Ltd | For treatment of leukaemia and lymphoma | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: <https://www.tga.gov.au/prescription-medicines-applications-under-evaluation>
The committee also provided advice on:
- Two applications for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see: <https://www.tga.gov.au/resources/auspar>
Section B: Post-market items
The ACM was not asked to provide advice on a post-market or safety issue.
Further information
For further information on the Advisory Committee on Medicines, please visit:
<https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-medicines-acm>
or contact the ACM Secretary by email: ACM@health.gov.au