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In this section: Cellular & Gene Therapy Products

TECELRA

STN: 125789
Proper Name: afamitresgene autoleucel
Tradename: TECELRA
Manufacturer: Adaptimmune LLC
Indication:

Treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared Companion Diagnostic devices.

Product Information

Package Insert - TECELRA

Supporting Documents

August 1, 2024 Approval Letter - TECELRA
August 1, 2024 Summary Basis for Regulatory Action - TECELRA
Approval History, Letters, Reviews, and Related Documents - TECELRA

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