Initial US Approval:
2024
Key Clinical Studies:
SPEARHEAD-1 (NCT04044768)
Drug Class/Description:
Melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy
Indications and Usage:
- 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 duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Dosage Administration:
For autologous use only.
For intravenous use only.
Prior to infusion:
- Verify patient’s identity prior to infusion.
- Administer a lymphodepleting regimen of cyclophosphamide and fludarabine.
- Premedicate with acetaminophen and an H1-antihistamine.
Dosage and Administration:
The recommended dose is between 2.68 x 109 to 10 x 109 MAGE-A4 T cell receptor (TCR) positive T cells.
Administer each infusion bag within one hour of thawing.
DO NOT USE a leukodepleting filter. DO NOT USE prophylactic systemic corticosteroids.
Dosage Forms and Strengths:
- A cell suspension for intravenous infusion.
- Provided in one or more infusion bag(s) containing 2.68 x 109 to 10 x 109 MAGE-A4 TCR positive T cells
Contraindications:
DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA-A*02:05P.
Warnings and Precautions:
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Monitor for ICANS events for at least 4 weeks after treatment with TECELRA.
Prolonged Severe Cytopenia: Patients may exhibit severe cytopenia (hemoglobin < 8.0 g/dL, neutrophils < 1,000/mm3 , platelets < 50,000/mm3 ) for several weeks following lymphodepleting chemotherapy and TECELRA infusion. Monitor blood counts prior to and after TECELRA infusion.
Infections: Monitor patients for signs and symptoms of infection; treat appropriately.
Secondary Malignancies: In the event that a secondary malignancy occurs after treatment with TECELRA, contact Adaptimmune at 1-855- 24MYADAP (1-855-246-9232).
Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion.
Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 4 weeks after receiving TECELRA.
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.
The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and pleural effusion.
Adapted from:
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
