Adaptimmune Receives FDA Accelerated Approval for TECELRA®, the First Engineered Cell Therapy for Solid Tumors
Adaptimmune Therapeutics has received approval from the U.S. FDA for TECELRA® (afamitresgene autoleucel).
This treatment is intended for adults with unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy and are positive for specific HLA-A types. It targets tumours that express the MAGE-A4 antigen, as determined by FDA-approved diagnostic devices.
TECELRA is the first cell therapy for a solid tumour cancer and represents the first new treatment for synovial sarcoma. Synovial sarcoma is a rare soft tissue cancer, primarily affecting young adults.
TECELRA can cause severe side effects, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and prolonged cytopenia, among others. The most common side effects include nausea, vomiting, fatigue, infections, and reduced blood cell counts.
Before starting treatment, patients will need biomarker tests to check for the relevant HLA type and tumour expression of the MAGE-A4 antigen. Adaptimmune has partnered with Agilent Technologies to develop a companion diagnostic for MAGE-A4, and with Thermo Fisher Scientific to expand diagnostic testing for HLA typing.
TECELRA is a genetically modified autologous T-cell therapy designed to target MAGE-A4, providing a much-needed new option for synovial sarcoma patients.
