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 European Medicines Agency (EMA) gave the investigational B-cell maturation antigen (BCMA) the designation based on results from the Phase I/II LEGEND-2 study (NCT03090659) evaluating LCAR-B38M CAR-T cells, and the Phase Ib/II CARTITUDE-1 study (NCT03548207) 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. ...