Guidelines for Use
GUIDELINES FOR USE
Our guideline named AFAMITRESGENE AUTOLEUCEL requires the following rule(s) be met for approval:
- You have a diagnosis of advanced synovial sarcoma (unresectable or metastatic)
- You are ≥ 18 and ≤ 75 years of age
- You meet BOTH of the following:
- You are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive
- You do not have HLA-A*02:05P in either allele
- You have the MAGE-A4 antigen as detected by a Food and Drug Administration (FDA)-approved test or cleared companion diagnostic devices
- Your disease has progressed following ≥ 1 or more prior systemic chemotherapy regimens
- You have not previously received Tecelra
- You do not meet ANY of the following:
- ECOG performance status greater than 1
- Absolute neutrophil count (ANC) less than or equal to 1 x 109/L
- Platelets less than 75,000/mm3
- Alanine transaminase (ALT) and aspartate transaminase (AST) greater than 2.5 times the upper limit of normal (ULN)
- Creatinine clearance less than 40 mL/min
- Left ventricular ejection fraction (LVEF) less than 40%
- Symptomatic central nervous system metastases
- History of another primary malignancy that is not considered to be in complete remission
- Infection that is uncontrolled or requires IV or long-term oral antimicrobial therapy
- HIV infection; hepatitis B or C virus infection permitted only if viral load undetectable; or human T-cell leukemia virus
- Any primary immunodeficiency