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Adaptimmune Aims To Quickly Convert Teclera’s Accelerated Approval

 
• By Bridget Silverman

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...

Confirmatory evidence is expected to be submitted to the FDA “next year to complete that obligation and convert this application to regular approval,” Adaptimmune CEO Adrian Rawcliffe told a teleconference...

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