The FDA is due to decide by 4th August whether to approve Adaptimmune’s engineered T-cell therapy for advanced synovial sarcoma, afamitresgene autoleucel (afami-cel), after a priority review.

The regulatory body has set a target action date of Aug 4, 2024. Per the company, afami-cel would be the first engineered T-cell therapy (for treating solid tumors) to receive commercial approval ...

It is based on the patient's own cells and is delivered as a one-time ... 1 trial published in The Lancet earlier this year, afami-cel demonstrated an objective response rate (ORR) of around ...

which focuses on providing novel cell therapies to people with cancer. Its clinical pipeline includes Afami-cel, Lete-cel, and ADP-A2M4CD8. The company was founded by Bent K. Jakobsen, James ...