Adaptimmune receives US FDA Accelerated Approval for engineered cell therapy for a solid tumour
James Spargo | August 2, 2024 | News story | Medical Communications | Adaptimmune, Oncology, accelerated approval, engineered cell therapy, oncology, synovial sarcoma
Adaptimmune Therapeutics has announced today that the US Food and Drug Administration (FDA) has given accelerated approval for TECELRA (afamitresgene autoleucel), the first engineered cell therapy for a solid tumour cancer approved in the US. It is a treatment for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy; are HLA-A*02:02P, -A*02:02P, -A*02:03P or -A*02:06P positive; and whose tumour expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA is the first new therapy option for synovial sarcoma – a rare, soft tissue cancer commonly impacting young adults – in over a decade.
The approval is based on the results of the 44-patient strong SPEARHEAD-1 (cohort 1) trial, where TECELRA achieved an overall response rate (ORR) of 43% and complete response rate of 4.5%. While the indication’s approval was based on this ORR duration of response data, it may be contingent upon verification and description of a clinical benefit in a confirmatory trial.
Adrian Rawcliffe, Adaptimmune’s CEO, commented: “The approval of TECELRA is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of ground-breaking R&D. I want to thank the patients, caregivers, investigators and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy and for people with synovial sarcoma.”
Sandra D’Angelo MD, Sarcoma medical oncologist and cell therapist, Memorial Sloan Kettering Cancer Center; SPEARHEAD Trial principal investigator, said: “TECELRA, which uses each patient’s own immune cells to recognise and attack their cancer cells in a one-time infusion treatment, is significantly different than the current standards of care for advanced synovial sarcoma. This approval represents a much-needed new option for people diagnosed with this sarcoma and an important milestone for the use of cell therapies in solid tumour cancers.”
James Spargo
2/8/24
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