TUESDAY, Aug. 6, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Tecelra (afamitresgene autoleucel), a gene therapy for the treatment of adults with unresectable or metastatic synovial sarcoma.
Specifically, the approval is for adults who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and have a tumor that expresses the MAGE-A4 antigen. The single-dose, intravenous T-cell immunotherapy is composed of a patient's own T-cells.
The approval was based on an open-label clinical trial of 44 patients with inoperable and metastatic synovial sarcoma. The overall response rate was 43.2 percent, and the median duration of response was six months. The most common adverse reactions seen with Tecelra included nausea, vomiting, fatigue, infections, fever, constipation, dyspnea, abdominal pain, noncardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.
"Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence," Nicole Verdun, M.D., director of the Office of Therapeutic Products in the FDA Center for Biologics Evaluation and Research, said in a statement. "Today's approval represents a significant milestone in the development of an innovative, safe, and effective therapy for patients with this rare but potentially fatal disease."
The approval of Tecelra was granted to Adaptimmune.
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