Adaptimmune Aims To Quickly Convert Teclera’s Accelerated Approval

 
• By Bridget Silverman
  
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The first engineered cell therapy for a solid tumor could be submitted for full approval in synovial sarcoma next year.

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Adaptimmune plans to fill out its Teclera label with confirmatory evidence to be submitted 2025. • Source: Shutterstock

In contrast to the many cell and gene therapy accelerated approvals that have been criticized for lengthy confirmatory trial timelines, Adaptimmune Therapeutics plc is gearing up for a relatively quick bid for full approval of its newly cleared melanoma-associated antigen A4 (MAGE-A4)-directed autologous T-cell immunotherapy Teclera (afamitresgene autoleucel).

Key Takeaways

  • Adaptimmune’s MAGE-A4 directed autologous T-cell therapy Teclera earned accelerated approval 1 August for chemotherapy-experienced synovial sarcoma patients who have specific HLA types and whose tumors express the MAGE-A4 antigen.

Confirmatory evidence is expected to be submitted to the FDA “next year to complete that obligation and convert this application...

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