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FDA Approves Adaptimmune's Groundbreaking T-Cell Therapy for Rare Cancer

Tecelra offers new hope for synovial sarcoma patients with limited treatment options

High magnification micrograph of a clear cell sarcoma in a tendon. It is also known as melanoma of the soft parts, due to its morphologic similarity to malignant melanoma. HPS stain. Clear cell sarcoma has a similar immunohistochemistry when compared to melanoma; however, unlike melanoma, it has a recurrent chromosomal translocation between EWSR1 and ATF1 -- t(12;22)(q13;q12).[1] It should not be confused with clear cell sarcoma of the kidney, a pediatric kidney tumour second only in prevalence to nephroblastoma (Wilms tumour).
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Overview

  • Tecelra is the first gene therapy approved in the U.S. that uses a patient's own T-cells to target cancer.
  • The therapy, priced at $727,000, received accelerated approval and requires further confirmatory trials.
  • Synovial sarcoma affects about 1,000 people annually in the U.S., primarily young adults.
  • In clinical trials, Tecelra showed a 43.2% response rate among participants, with effects lasting an average of six months.
  • The treatment carries a risk of severe cytokine release syndrome, a dangerous immune response.