- cafead Mar 04, 2024 at 12:02: PM
via Iovance Biotherapeutics ended 2023 on a downer courtesy of a partial clinical hold from the FDA, but the situation has been resolved relatively quickly.
The agency implemented the hold on the phase 2 trial of tumor-infiltrating lymphocyte therapy LN-145 on Dec. 22 after a grade 5 adverse event—which signifies a patient fatality—was reported. The death was potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen, Iovance explained at the time.
article source
The agency implemented the hold on the phase 2 trial of tumor-infiltrating lymphocyte therapy LN-145 on Dec. 22 after a grade 5 adverse event—which signifies a patient fatality—was reported. The death was potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen, Iovance explained at the time.
article source