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Inclusions of new biologicals

2 September 2020

Each year, TGA approves new biologicals for inclusion in the Australian Register of Therapeutic Goods (ARTG).

The decision to approve a new biological comes after a comprehensive review by TGA scientists and clinicians of the product’s quality, safety and efficacy of the proposed use of the biological. TGA classifies biologicals according to the level of risk to patients associated with their use and may be either Class 1 (lowest risk), Class 2, Class 3, or Class 4 (highest risk) biologicals.

The trade name, active ingredient, type of cell or tissue, and sponsor for each new biological reflects the information initially included in the ARTG.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, time allocated to the sponsor to respond to requests for information, and 'mutual clock stop' periods agreed with the sponsor.

From 2018, approval times are reported in the number of TGA working days for each decision, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.


Previous years

2018

Inclusions of new biologicals, 2020

February 2020

YESCARTA

Evaluation commenced: 20 Dec 2018

Registration decision: 11 Feb 2020

Date registered: 11 Feb 2020

Approval time: 199 working days (255)

T Cells - axicabtagene ciloleucel, cryopreserved - T - Yescarta

Gilead Sciences Pty Ltd

Class 4 biological

YESCARTA is a genetically modified autologous immunocellular therapy for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.