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Adaptimmune Therapeutics Gets Accelerated Approval of Tecelra From FDA
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Adaptimmune Therapeutics Gets Accelerated Approval of Tecelra From FDA
Aug 2, 2024 2:31 AM

05:11 AM EDT, 08/02/2024 (MT Newswires) -- Adaptimmune Therapeutics ( ADAP ) said Thursday that the US Food and Drug Administration has granted accelerated approval of Tecelra for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy.

The accelerated approval is based on the overall response rate and duration of response, the company said, adding that continued approval may be dependent upon verification and description of clinical benefit in a confirmatory trial.

Tecelra, or afamitresgene autoleucel, is the first engineered cell therapy for solid tumor cancer approved in the US, the company said.

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