PRIME (PRIority MEdicines) designation based on clinical study results evaluating safety and efficacy of novel CAR-T therapy in the treatment of patients with advanced relapsed or refractory multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) designation for the company’s investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-68284528 (JNJ-4528). PRIME offers enhanced interaction and early dialogue to optimise development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.[1]
‘The PRIME designation of this novel BCMA CAR-T therapy highlights the value of regulatory innovation in the European Union,’ said Sjaak Bot, Vice President, Head EMEA Regulatory Affairs at Janssen Biologics B.V. ‘We hope to bring this important advance to patients as quickly as possible and this PRIME designation, the first for Janssen, marks an important milestone towards potential market approval.’
The PRIME designation is based on results from the Phase 1/2 LEGEND-2 study (NCT03090659) evaluating LCAR-B38M CAR-T cells, sponsored by Nanjing Legend Biotech Co.,[2] and the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating JNJ-4528, sponsored by Janssen and being conducted in collaboration with Legend Biotech USA Inc.[3] Results from the LEGEND-2 study were presented at the American Society of Hematology (ASH) 2018 annual meeting.[4] Results from the CARTITUDE-1 study will be presented in the future.
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