Posted by Michael Wonder on 04 Apr 2019
EMA grants PRIME designation to Janssen’s investigational CAR-T therapy
4 April 2019 - Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its CAR-T therapy JNJ-68284528 (JNJ-4528) in multiple myeloma.
The EMA gave the investigational B-cell maturation antigen (BCMA) the designation based on results from the Phase I/II LEGEND-2 study evaluating LCAR-B38M CAR-T cells, and the Phase Ib/II CARTITUDE-1 study evaluating JNJ-4528.
The clinical study results evaluated the safety and efficacy of the novel therapy, and found that there was an 88% overall response rate in the treatment of patients with advanced relapsed or refractory multiple myeloma.
