FDA Approves Tecelra, the First Engineered Cell Therapy for Solid Tumors, to Treat Synovial Sarcoma

FDA Approval:
The FDA has approved Tecelra (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and whose tumors express the MAGE-A4 antigen.

First Engineered Cell Therapy for Solid Tumors:
Tecelra is the first engineered cell therapy to be approved by the FDA for a solid tumor, marking a significant milestone in cancer treatment.

TCR Cell Therapy:
Tecelra is a T cell receptor (TCR) gene therapy, which modifies a patient's T cells to target the MAGE-A4 antigen expressed by cancer cells in synovial sarcoma.

Clinical Efficacy:
The approval was based on a clinical trial showing a 43% overall response rate, with responses lasting a median of about 6 months. Continued approval is contingent on verification of clinical benefit in an ongoing confirmatory trial.

List Price:
Tecelra is priced at $727,000 per dose, reflecting its clinical value for patients with a rare and aggressive form of cancer.

Availability:
The therapy will be available at authorized treatment centers, with Adaptimmune planning to have six to ten centers operational this year and 30 within two years.

Patient Eligibility:
Patients must be HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive and have tumors that express the MAGE-A4 antigen.

Side Effects:
Patients may experience Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), infections, secondary malignancies, hypersensitivity reactions, and severe cytopenia.

Historical Context:
This approval marks the first new treatment for synovial sarcoma in over a decade, a rare and aggressive cancer primarily affecting young adults.

Future Plans:
Adaptimmune plans to submit results from the ongoing confirmatory trial next year and is also exploring the use of Tecelra in pediatric patients.