24/7 Market News- Adaptimmune Receives Accelerated FDA Approval of TECELRA

August 2, 2024

DENVER, Colo., Aug 02, 2024 (247marketnews.com)- Adaptimmune Therapeutics plc (NASDAQ: ADAP) stated that U.S. Food and Drug Administration (FDA) granted accelerated approval of TECELRA (afamitresgene autoleucel), for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, based on overall response rate and duration of response.

Adaptimmune’s Chief Executive Officer, Adrian Rawcliffe, 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. We are committed to advancing our robust clinical pipeline to serve more patients in need and plan to progress lete-cel, the next late-stage investigational treatment in our sarcoma franchise, with a rolling BLA submission to the FDA next year.”

The continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Sarcoma Foundation of America’s CEO, Brandi Felser, said, “For decades, therapeutic options for people diagnosed with synovial sarcoma have been limited. With a current five-year survival rate as low as 36%, and for those with metastatic disease at diagnosis, as low as 20%, it is long past time that synovial sarcoma patients have expanded treatment options. Since one third of patients are diagnosed under age 30, improved outcomes can have a tremendous impact. Today, there is a renewed sense of hope for this patient community.”

The SPEARHEAD Trial Principal Investigator, Sandra D’Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center, added, “TECELRA (afami-cel), which uses each patient’s own immune cells to recognize 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 tumor cancers.”

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