American Society for Transplantation and Cellular Therapy Applauds FDA Approval of TECELRA® for Synovial Sarcoma Treatment

The American Society for Transplantation and Cellular Therapy (ASTCT®) applauds the U.S. Food and Drug Administration's (FDA) accelerated approval of TECELRA® (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy. This groundbreaking therapy offers a new treatment option for patients with this rare, soft tissue cancer, marking a significant advancement in cellular therapy.

Developed by Adaptimmune Therapeutics plc, TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new treatment option in over a decade for synovial sarcoma. The approval is based on the overall response rate and duration of response in patients, as demonstrated in the pivotal SPEARHEAD-1 (Cohort 1) trial, which showed a 43% overall response rate with a complete response rate of 4.5%.

 "This approval is a testament to the collaborative efforts between researchers, clinicians, and industry partners dedicated to advancing the science of cellular therapy," said Corey Cutler, MD, MPH, FRCPC, President of ASTCT.

ASTCT has long advocated for innovation and excellence in clinical care through cellular therapies, striving to improve outcomes for patients with hematopoietic cell transplantation and related cellular therapies. ASTCT believes that TECELRA's approval will significantly impact the synovial sarcoma community, providing new opportunities for patients and healthcare professionals alike.

For more information about TECELRA and its availability, healthcare professionals and patients are encouraged to contact Adaptimmune directly.

About The American Society for Transplantation and Cellular Therapy® (ASTCT®):

The American Society for Transplantation and Cellular Therapy (ASTCT) is an international professional society dedicated to improving the lives of blood and marrow transplant and cellular therapy patients. ASTCT represents more than 3,900 physicians, investigators, and other health care professionals from more than 45 countries. Our mission is dedicated to improving the application and success of blood and marrow transplantation and related cellular therapies. We strive to be the leading organization promoting research, education, and clinical practice in the field. For more information about ASTCT, visit www.astct.org.

Source: The American Society for Transplantation and Cellular Therapy (ASTCT®)