pharmaphorum August 2, 2024
The FDA has given accelerated approval to a groundbreaking T cell-based therapy from Adaptimmune for synovial sarcoma, becoming the first new treatment for the rare soft tissue cancer in more than a decade.
Tecelra (afamitresgene autoleucel) has also become the first FDA-approved, engineered T-cell therapy for solid tumours, and is indicated for adults with unresectable or metastatic synovial sarcoma when other prior chemotherapy does not work, according to the Anglo-American biotech. It is based on the patient’s own cells and is delivered as a one-time infusion.
Synovial sarcomas arise in muscle and connective tissue and account for approximately 5% to 10% of all soft tissue sarcomas in the US, of which there are approximately 13,400 new cases each year, mainly...