Policy & Regulation
European Medicines Agency grants PRIME designation to Tessa Therapeutics' lead autologous CD30 CAR-T therapy
19 January 2021 -

The European Medicines Agency (EMA) has granted PRiority Medicines (PRIME) designation to Singapore-based Tessa Therapeutics' lead autologous CD30 CAR-T therapy intended for the treatment of relapsed or refractory classical Hodgkin Lymphoma, it was reported on Monday.

PRIME is intended to optimise development plans and accelerate assessment of medicines that showcase major therapeutic advantage over present treatments, or otherwise benefit patients without treatment options. The EMA also provides improved support to medicine developers including early interaction and dialogue, and a pathway for accelerated assessment by the agency.

The PRIME designation was offered to Tessa based on the clinical data from two Phase I/II trials in R/R cHL conducted at Baylor College of Medicine and University of North Carolina Lineberger Comprehensive Cancer Center. These studies indicated complete disappearance of tumour in around 60% of patients at the highest dose level, with none of the serious toxicities that can be linked to several other CAR-T therapies.