ACM meeting statement, Meeting 49, 6 and 7 February 2025
Section A: Premarket registration applications
At this meeting, the committee provided advice on 13 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) | |||
leniolisib phosphate (JOENJA) | Ballia Holdings Pty Ltd | Activated phosphoinositide 3-kinase delta syndrome | Priority Orphan |
futibatinib (LYTGOBI) | Taiho Pharma Oceania Pty Ltd | Advanced or metastatic cholangiocarcinoma | Provisional Orphan |
inebilizumab (UPLIZNA) | Amgen Australia Pty Ltd | Neuromyelitis optica spectrum disorders | |
lazertinib mesilate monohydrate (LAZCLUZE) | Janssen-Cilag Pty Ltd | Locally advanced or metastatic non-small cell lung cancer | |
elafibranor (IQIRVO) | Ipsen Pty Ltd | Primary biliary cholangitis | |
velmanase alfa (LAMZEDE) | Chiesi Australia PTY LTD | Alpha-mannosidosis | Orphan |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
tenecteplase (METALYSE) | Boehringer Ingelheim Pty Ltd | Acute ischaemic stroke | |
olaparib (LYNPARZA) | AstraZeneca Pty Ltd | Advanced or recurrent endometrial cancer | |
durvalumab (IMFINZI) | AstraZeneca Pty Ltd | Advanced or recurrent endometrial cancer | Priority |
bimekizumab (BIMZELX) | UCB Australia Pty Ltd | Moderate to severe hidradenitis suppurativa | |
amivantamab (RYBREVANT) | Janssen-Cilag Pty Ltd | Locally advanced or metastatic non-small cell lung cancer | |
elexacaftor, ivacaftor, tezacaftor (TRIKAFTA) | Vertex Pharmaceuticals | Cystic fibrosis | Orphan |
melphalan hydrochloride (PHELINUN) | Link Medical Products Pty Ltd | Conditioning regimen prior to haematopoietic stem cell transplantation in malignant haematological diseases. | Orphan |
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
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
Advisory Committee on Medicines (ACM)
or contact the ACM Secretary by email: ACM@health.gov.au