FDA accelerated approval for Tecelra (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy
Adaptimmune Therapeutics plc a company working to redefine the treatment of solid tumor cancers with cell therapy, announced FDA accelerated approval of Tecelra (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A2:01P, -A02:02P, -A02:03P, or -A02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Tecelra is the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.
See- Volume 403, ISSUE 10435, P1460-1471, April 13, 2024; "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase II trial": Sandra P D'Angelo, MD, Prof Dejka M Araujo, MD, Albiruni R Abdul Razak, MBBCh, Prof Mark Agulnik, MD. Steven Attia, DO, Prof Jean-Yves Blay, MD, et al. Published:March 27, 2024DOI:https://doi.org/10.1016/S0140-6736(24)00319-2.
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