Approvals

Adaptimmune Therapeutics has announced 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 therpay 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.

The SPEARHEAD-1 trial data was previously published in The Lancet earlier this year.

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 groundbreaking 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.”

“For decades, therapeutic options for people diagnosed with synovial sarcoma have been limited. It is long past time that synovial sarcoma patients have expanded treatment options. Today, there is a renewed sense of hope for this patient community.” added Brandi Felser, chief executive officer of the Sarcoma Foundation of America.