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TECARTUS (Gilead Sciences Pty Ltd)
Product name
TECARTUS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
210 (255 working days)
Active ingredients
T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus
Registration type
Biologicals
Indication
Class 4 biological
TECARTUS is a genetically modified autologous immunocellular therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), who have received two or more lines of therapy, including a BTK inhibitor, unless ineligible or intolerant to treatment with a BTK inhibitor.