MedPage Today August 2, 2024
— Afamitresgene autoleucel (Tecelra) approved for metastatic synovial sarcoma
The FDA granted accelerated approval to afamitresgene autoleucel (afami-cel, Tecelra) for treating advanced synovial sarcoma, the first engineered cell therapy indicated for a solid tumor.
An autologous T-cell immunotherapy, afami-cel is specifically indicated for adults with unresectable or metastatic disease who have received prior chemotherapy. For eligibility, patients need to be HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and have a tumor that expresses the MAGE-A4 antigen, as determined by a companion diagnostic.
With the approval, the T-cell receptor gene therapy becomes the first new therapeutic option in over a decade for synovial sarcoma, a rare soft-tissue cancer that most commonly develops in the extremities.
“Potentially life-threatening cancers such as synovial sarcoma...
Today's Sponsors
Today's Sponsor