Tecelra (afamitresgene autoleucel) — Medica

Initial criteria

• Patient age ≥ 18 years
• Patient has advanced, unresectable, or metastatic disease
• Patient is human leukocyte antigen (HLA) positive for at least ONE of the following: HLA-A•02:01P, HLA-A•02:02P, HLA-A•02:03P, or HLA-A•02:06P
• Patient is NOT heterozygous or homozygous for HLA-A•02:05P
• Tumor expresses melanoma-associated antigen A4 (MAGE-A4)
• Patient has received prior chemotherapy
• Patient received or plans to receive lymphodepleting chemotherapy prior to Tecelra infusion
• Patient has not been previously treated with Tecelra
• Medication is prescribed by or in consultation with an oncologist

Approval duration

6 months (single dose)