The European Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) designation for the Janssen Pharmaceutical Companies of Johnson & Johnson’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.
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., 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.
Results from the LEGEND-2 study were presented at the American Society of Hematology (ASH) 2018 annual meeting. Results from the CARTITUDE-1 study will be presented in the future.
JNJ-4528 is currently being investigated for the treatment of patients with multiple myeloma who have received at least three prior regimens, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody, and have documented disease progression within 12 months of starting the most recent therapy, or are double refractory to an IMiD and PI. These patients have few available treatment options and are often faced with poor outcomes.
Sjaak Bot, Vice President, Head EMEA Regulatory Affairs at Janssen Biologics B.V., said: “The PRIME designation of this novel BCMA CAR-T therapy highlights the value of regulatory innovation in the European Union.
“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.”
Dr Sen Zhuang, Ph.D., Vice President, Oncology Clinical Development, Janssen Research & Development, LLC., said: “We continue to advance this novel BCMA targeted CAR-T therapy through clinical studies globally as we strive to bring it to the patients with multiple myeloma around the world.”