On Friday, the U.S. Food and Drug Administration (FDA) granted approval to Adaptimmune’s groundbreaking therapy for a rare form of soft tissue cancer primarily affecting younger patients. The treatment, named Tecelra, is designed to target synovial sarcoma—a serious cancer that can be life-threatening—specifically for patients who have undergone previous chemotherapy.
Tecelra, which is administered as a one-time intravenous infusion, leverages the patient’s own modified T-cells to combat the disease. This novel approach contrasts with existing treatments for soft tissue sarcoma, which include Novartis’ Votrient, surgery, chemotherapy, and radiotherapy. The list price for Tecelra is set at $727,000, a figure comparable to the cost of CAR-T cell therapies, which typically average around $500,000.
The therapy comes with a serious warning about cytokine release syndrome, a severe immune reaction that can be dangerous. Despite this risk, Dr. Sandra D’Angelo, an oncologist at Memorial Sloan Kettering Cancer Center, believes that Tecelra’s approach could offer new treatment possibilities for other solid tumors by targeting a wider range of tumor-associated proteins than current therapies.
The FDA’s accelerated approval of Tecelra was supported by data from a study involving 44 patients, where 43.2% experienced either partial or complete responses to the therapy, with effects lasting an average of six months. Synovial sarcoma, which often manifests in the extremities, affects approximately 1,000 individuals in the U.S. annually.
Guggenheim analyst Michael Schmidt projects peak U.S. sales for Tecelra could reach $180 million. However, despite the promising approval news, Adaptimmune’s stock saw a 7% decline in afternoon trading, though it has gained 46% so far this year
