Afamitresgene Autoleucel

1 INDICATIONS AND USAGE TECELRA is a melanoma-associated antigen A4-(MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated 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. This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

6 ADVERSE REACTIONS Most common adverse reactions (≥ 20%) were, cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema. Grade 3 or 4 laboratory abnormalities (≥20%) were lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased ( 6.1 ). The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and pleural effusion ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact USWM CT, LLC at 1-855-246-9232 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no available data with TECELRA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with TECELRA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if TECELRA has the potential to be transferred to the fetus and cause fetal toxicity. Therefore, TECELRA is not recommended for women who are pregnant, and pregnancy after TECELRA administration should be discussed with the treating physician. Report all pregnancies following treatment with TECELRA to 1-855-246-9232.

WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving TECELRA. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS [see Preparation and Administration ( 2.2 ), and Warnings and Precautions ( 5.1 )] . 5 WARNINGS AND PRECAUTIONS Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) : Monitor for ICANS events for at least 4 weeks after treatment with TECELRA ( 5.2 ). Prolonged Severe Cytopenia : Patients may exhibit severe cytopenia (hemoglobin < 8.0 g/dL, neutrophils < 1,000/mm 3 , platelets < 50,000/mm 3 ) for several weeks following lymphodepleting chemotherapy and TECELRA infusion. Monitor blood counts prior to and after TECELRA infusion ( 5.3 ). Infections : Monitor patients for signs and symptoms of infection; treat appropriately ( 5.4 ). Secondary Malignancies : In the event that a secondary malignancy occurs after treatment with TECELRA, contact 1-855-246-9232 ( 5.5 ). Hypersensitivity Reactions : Monitor for hypersensitivity reactions during infusion ( 5.6 ). 4 CONTRAINDICATIONS DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA- A*02:05P. DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA-A*02:05P ( 4 ).