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Premarket inclusion applications
At this meeting, the committee provided advice on 3 applications under evaluation by the TGA, as below.
| Product (TRADENAME) | Product Type | Classification | Sponsor |
|---|---|---|---|
| Applications for a new biological not currently approved in Australia | |||
Lisocabtagene maraleucel (BREYANZI) | CAR-T cell | Class 4 Biological | Bristol-Myers Squibb Australia |
| Applications for a variation to an existing biological currently included in the ARTG | |||
Axicabtagene ciloleucel (YESCARTA) | CAR-T cell | Class 4 Biological | Gilead Sciences |
Brexucabtagene autoleucel (TECARTUS) | CAR-T cell | Class 4 Biological | Gilead Sciences |
Further information
For further information on the Advisory Committee on Biologicals please visit: Advisory Committee on Biologicals or contact the committee support unit by email at MRDCommitteeSupport@health.gov.au.