In response to the FDA approval of afamitresgene autoleucel for the treatment of unresectable or metastatic synovial sarcoma, the panel requested the addition of afamitresgene autoleucel on SARC-G-1 for this indication.

We request a new algorithm page for synovial sarcoma following “Special considerations for unique histologies” that includes the following:

Testing for HLA-A2 serotype and MAGE-A4 antigen as a branch point for treatment.

Afamitresgene autoleucel as a preferred treatment after prior chemotherapy for appropriate patients based on HLA-A2 and MAGE-A4 testing.

A footnote appended to afamitresgene autoleucel, “FDA-approved for the 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.”

Request new heading for synovial sarcoma and include afamitresgene autoleucel as a category 2A, preferred recommendation.

Append the following footnote to afamitresgene autoleucel, “FDA-approved for the 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.”

Update corresponding sections of the discussion